{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "SUITE 3300", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MONTREAL, QUEBEC", "manufacturer_contact_address_1": "56 E. BELL DR.", "manufacturer_contact_pcity": "90163340", "event_type": "Injury", "report_number": "0009617840-2024-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240509", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20240429", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9016334069", "noe_summarized": "1", "manufacturer_contact_l_name": "LASHLEY", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "901", "date_added": "20240509", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20220218", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "489526", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240509", "brand_name": "ROSA RECON PLATFORM 220V", "generic_name": "ROBOTIC SURGICAL ARM SYSTEM", "manufacturer_d_name": "ZIMMER CAS", "manufacturer_d_address_1": "75 QUEEN STR.", "manufacturer_d_address_2": "SUITE 3300", "manufacturer_d_city": "MONTREAL, QUEBEC", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "20-8020-100-26", "lot_number": "1.2.4.13", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/06/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250821", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "N6", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9016", "patient": [ { "patient_sequence_number": "1", "date_received": "20240509", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " O" ], "patient_age": "57 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250211", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "19281287", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240430", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "H3C 2", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ZIMMER CAS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "342144749", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). G2: FOREIGN: GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS ON THE CUSTOMER SITE; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED." }, { "mdr_text_key": "342144750", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY WHICH HAD TO BE CANCELLED DURING THE PROCEDURE AS THE DISTAL RESECTION RESULTED IN SEVERE VALGUS.ALL LANDMARKS WERE TAKEN CORRECTLY AND NO DRIFTING OCCURRED DURING THE RESECTION. THE BONE HAD TO BE REBUILT WITH WEDGES. THERE WAS A 30 (THIRTY) MINUTE DELAY TO REBUILD THE BONE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "364112222", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4, D4, G3, G6, H2, H6, H11. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER. THE UNIT PASSED A FULL PREVENTATIVE MAINTENANCE WITHOUT ISSUES AND WAS CLEARED FOR FURTHER CLINICAL USAGE AS FULLY FUNCTIONAL. THE INITIALLY PROVIDED X-RAY IMAGES WERE NOT ASSESSED AS THEY ARE POST-OPERATIVE, TAKEN AFTER THE BONE WAS REBUILT INTRAOPERATIVELY. THE INTRAOPERATIVE VALGUS CONDITION CANNOT BE ACCURATELY CAPTURED ON POST-OPERATIVE IMAGES. AFTER FURTHER COMMUNICATIONS WITH THE REPORTER, A PRE-OPERATIVE X-RAY WAS PROVIDED BUT NOT ASSESSED AS THE INTRAOPERATIVE VALGUS CONDITION CANNOT BE ACCURATELY CAPTURE ON A PRE-OPERATIVE IMAGE. THE PROVIDED INVESTIGATION LOGS WERE ANALYZED BY A SUBJECT MATTER EXPERT. THE LOGS DO NOT CONFIRM THE REPORTED ISSUE AS THERE ARE TWO SAVED LIGAMENTS BALANCING ASSESSMENTS IN EXTENSION MADE AFTER THE DISTAL CUTS THAT SHOW THE PRESENCE OF AN UNCORRECTABLE VARUS OF ABOUT 2.6 DEGREES, WHICH WAS ALSO PRESENT AT THE INITIAL GAPS ASSESSMENT. THUS, BASED ON THE LIGAMENT BALANCING RESULTS, THE LEG PRESENTED NO SIGN OF UNPLANNED VALGUS AFTER THE FIRST DISTAL CUT, NOR THE SECOND DISTAL CUT. YET, THE LATERAL GAP AT BALANCING TOOL (6-7MM) WAS QUITE LARGER THAN AT INITIAL GAPS (VERSUS 2.6MM), WHICH COINCIDES WITH MORE VARUS OBTAINED WHEN THE KNEE WAS STRESSED. THE COMPLAINT MENTIONS A 5MM LATERAL WEDGE WAS NECESSARY TO COMPENSATE FOR THE ADDED LATERAL LAXITY OR VALGUS ALIGNMENT. NOTE THAT THE VALIDATIONS VALUES DID NOT SHOW ANY IMPORTANT EXTRA VALGUS. BASED ON ADDITIONAL INFORMATION FROM THE REPORTER, THE REPORTER INDICATED THAT THE SURGEON AGREED WITH THE HKA AND GAPS VALUES OBTAINED AT THE INITIAL KNEE EVALUATION AND AT THE FEMORAL ROTATION TOOL ASSESSMENT. THE INITIAL ASSESSMENT HAD A MAX VV IN EXTENSION FOR THE STRESSED KNEE AT 2.6 TO 11.5 DEGREES VARUS, THUS AN APPROXIMATE HKA OF 7.1 DEGREES VARUS. GAPS WERE 2.6MM LATERALLY AND 4.0MM MEDIALLY. THE FEMORAL ROTATION TOOL SHOWED A MAX VV IN EXTENSION FOR THE STRESSED KNEE WAS 3.5 TO 15.1 DEGREES VARUS, THUS AN APPROXIMATE HKA OF 9.3 DEGREES VARUS. GAPS WERE 6.7MM LATERALLY AND 0MM MEDIALLY ASSUMING A SPACER OF 19MM. THE LARGER LATERAL GAP MATCHES WITH MORE VARUS OBTAINED UNDER STRESS. THE INTRA-OP LANDMARKS WERE LOADED TO ANALYZE THEIR RELATIVE POSITIONS. THE CANAL ENTRY AND THE POSTERIOR WHITESIDE POINTS WERE TAKEN ALMOST ON THE SAME SPOT. THE CANAL ENTRY APPEARS POSSIBLY MORE LATERAL RATHER THAN CENTERED ON THE BONE, AS IT IS CLOSER TO THE LATERAL EPICONDYLE AND THE DISTAL POINTS BY ABOUT 9MM COMPARED TO THE MEDIAL POINTS. HOWEVER, THE POSTERIOR CONDYLES ARE EQUALLY POSITIONED ON EACH SIDE OF THE CANAL ENTRY. THE LOGS DO CONFIRM SOME UNEXPECTED ADDITIONAL LAXITY ON THE LATERAL SIDE, WHICH THE SURGEON MAY HAVE INTERPRETED TO BE ADDED VALGUS IN THE DISTAL CUT. THE POSSIBLE ADDED VALGUS WAS HOWEVER NOT CAPTURED BY THE VALIDATION. THERE WAS NO FINAL KNEE EVALUATION PERFORMED TO COMPARE TO THE INITIAL KNEE GAPS, AND THE SURGEON REVERTED TO CONVENTIONAL TECHNIQUE PRIOR TO PERFORMING THE 4-IN-1 DRILLED HOLES, SO LITTLE INFORMATION IS AVAILABLE POST CUTS TO COMPARE WITH THE INITIAL KNEE EVALUATION. THE MEDIO-LATERAL DISTANCE IN BETWEEN THE TWO BONES AXIS HAD SOME VARIATIONS OVER THE DIFFERENT SURGICAL STEPS, WHICH DOES NOT ALLOW TO EXCLUDE A POTENTIAL BONE TRACKER MOVEMENT. THE ML VALUE IN FLEXION AT 111 DEGREES WAS OF 4 TO 6.5MM FOR THE TIBIA CUT, AND THEN FOR THE SAME FLEXION ANGLE, IT REDUCED TO 2.5 TO 3MM FOR THE FIRST DISTAL FEMUR FLOW. THEN, FOR THE CANCELLED AND SECOND DISTAL FLOW, IT REDUCED AGAIN TO -0.5 TO 1.5MM, THIS TIME FOR A SLIGHTLY INCREASED OF THE LEG FLEXION TO 117 DEGREES. DURING THE FEMORAL ROTATION TOOL, THE ML DISTANCE VARIED GREATLY AT ABOUT -7.5MM. FINALLY, AT 118 DEGREES OF FLEXION (THUS SAME POSITION), THE ML DISTANCE WAS OF 3.5 TO 4MM FOR THE 4-IN-1 FLOW. THE ML ANALYSIS CANNOT SPECIFY IF IT WAS A TIBIA OR FEMUR TRACKER POTENTIAL MOVEMENT, BUT AS THE DISCREPANCY IS REPORTED FOR THE FEMUR, A FEMUR TRACKER MOVEMENT REMAINS A POSSIBILITY. THE VALUES SAVED DURING THE TWO LIGAMENT BALANCING TESTS PERFORMED AFTER THE TWO DISTAL CUTS SHOWED COHERENT VALUES COMPARED TO THE INITIAL KNEE ASSESSMENT, WITH AN UNCORRECTABLE VARUS OF ABOUT 2.6 DEGREES. THIS ASPECT REDUCES THE LIKELIHOOD OF A FEMUR TRACKER MOVEMENT. THERE WERE DIFFERENT SMALL MOVEMENTS IN TRANSLATION DETECTED DURING THE FLOW ASSOCIATED WITH SMALL CHANGES IN ORIENTATION. IN BETWEEN THE START OF THE TIBIA STATIONARY MODE UNTIL THE START OF THE FIRST DISTAL FLOW IN AUTOMATIC MODE (10:47:45 - 10:49:14), THERE WAS A 3.52MM MOVEMENT WITH A 0.16 DEGREES ORIENTATION CHANGE. THIS VARIATION COULD IMPACT THE FIRST DISTAL CUT PLANE BY UP TO 2.4MM IN THE WORST CASE. THERE WERE THEN FOUR MOVEMENTS WITHIN 15 SECONDS (10:57:07 TO 10:57:22) DURING THE COOPERATIVE MODE OF THE CANCELLED DISTAL FLOW. THE CHANGES WERE FROM 0.80MM TO 2.55MM, ORIENTATION VARYING FROM 0.07 DEGREES TO 0.11 DEGREES. THE DISTAL FEMUR FLOWS WERE PERFORMED IN COLLABORATIVE MODE AS CONFIRMED BY THE COMPLAINT AUTHOR'S ADDITIONAL INFORMATION AND SHORT DURATION OF THE DISTAL FEMUR STATIONARY MODE. CUTTING IN COLLABORATIVE MODE CAN INTRODUCE MORE INACCURACIES. HOWEVER, THE IMPACT OF THIS ERROR ON THE REPORTED INACCURACY CANNOT BE DEFINITIVELY VERIFIED. THE SIX-POINT REGISTRATION WAS COMPLETED WITHIN THE THRESHOLD. THE CUT GUIDE CHECKPOINT PASSED WITH A DEVIATION OF 0.725MM. THE SYSTEM RESPONDED AS EXPECTED WITH NO INDICATIONS THAT A SOFTWARE OR HARDWARE ANOMALY THAT MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE LOGS PROVIDE NO CLEAR EVIDENCE THAT COULD EXPLAIN WITH CONFIDENCE THE ADDED VALGUS OR ADDITIONAL LATERAL LAXITY. THE SERIAL NUMBER OF THIS DEVICE WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE SERVICING/MAINTENANCE PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED; THEREFORE, IT IS NOT EXPECTED THAT THE SERVICING/MAINTENANCE PROCESS CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS PREVIOUSLY SERVICED, AND NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND. WITH THE INFORMATION CURRENTLY AVAILABLE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED INACCURACIES CANNOT BE DETERMINED. FURTHERMORE, AS THE LOGS DO NOT CONFIRM THE REPORTED ISSUE, THE EVENT CANNOT BE CONFIRMED AT THIS TIME. IT WAS IDENTIFIED DURING INVESTIGATION THAT THE RESECTIONS WERE PERFORMED WHILE IN COLLABORATIVE MODE. THE ROSA KNEE USER MANUAL AND SURGICAL TECHNIQUE INDICATE THAT RESECTIONS SHOULD BE PERFORMED WHILE THE ROBOT IS IN STATIONARY MODE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS." }, { "mdr_text_key": "364112223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "75 QUEEN STR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46582", "manufacturer_contact_exchange": "901", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/11/2025" } ] }