{ "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": "0009617840-2023-00012", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230717", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20230606", "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": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "901", "date_added": "20230717", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20230309", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1488471", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230717", "brand_name": "ROSA KNEE PLATFORM US PL B", "generic_name": "ROBOTICS, KNEE", "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": "20-8020-100-01", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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 Measurement", "Incorrect Measurement" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/14/2023;02/18/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250813", "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": "20230717", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250314", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "17332346", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230627", "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": "338915968", "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 . H1: UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT DURING THE TRIALING AND IMPLANTATION PROCESS, IT IS NORMAL PRACTICE TO MAKE INTRAOP DECISIONS AND SIZE ADJUSTMENTS BASED UPON FIT AND FEEL FEEDBACK. WHEN AN ABNORMALITY IN ANATOMY OR FIT IS NOTED, IT IS COMMON TO USE BONE CEMENT, BONE FILLERS, AUTOGRAFT/ALLOGRAFT BONE, OR AUGMENTS TO BALANCE AND STABILIZE THE JOINT DURING THE HEALING PROCESS. IN THIS PARTICULAR CASE, THE SURGEON CHOSE A SCREW TO NORMALIZE THE JOINT SPACE. THERE WERE NO FRACTURES OR HARM TO THE HEALTHY BONE, AND THE IMPLANTS WERE PLACED SUCCESSFULLY WITHOUT REPORTED COMPLICATION. THEREFORE, THIS EVENT IS NOT CONSIDERED A SERIOUS INJURY. REPORTED EVENT WAS CONFIRMED BY REVIEW OF LOG FILES. INVESTIGATION LOG FILES OF THE REPORTED ERROR WERE PROVIDED WITH THE PER SUBMISSION, REVIEWED BY A SUBJECT MATTER EXPERT, AND CONFIRMED THE REPORTED EVENT. THE LOGS CONFIRMED THE FIRST VALIDATION OF THE FEMUR DISTAL CUT SHOWED ABOUT 4MM OVER-RESECTION ON BOTH SIDES. THE FOLLOWING FACTS WERE OBSERVED IN THE LOGS: ANALYSIS OF THE POSITIONS AND ORIENTATIONS OF THE BASE TRACKER SHOWED NO DISPLACEMENT AFTER SIX-POINT REGISTRATION BUT SHOWED A NOTICEABLE CHANGE OF ORIENTATION 0.5 DEGREES BETWEEN THE END OF THE SIX-POINT REGISTRATION AND THE INITIATION OF THE PROBLEMATIC FEMUR DISTAL CUT. THIS WOULD HAVE MOST LIKELY CONTRIBUTED TO THE ISSUE WITH THE FEMUR DISTAL CUT, ESPECIALLY BECAUSE THE CUT GUIDE CHECKPOINT WAS HIGH AS WELL, 2.11MM. THE SURGEON PERFORMS HIS CUTS IN COLLABORATIVE MODE WHICH COULD CREATE INSTABILITY BETWEEN THE BONE AND THE CUT GUIDE AS THERE IS NO PINNING. THE ML DISTANCE TENDS TO CHANGE WHEN THE FLEXION OF THE LEG CHANGES, WHICH COULD INDICATE SOME INSTABILITY OF ONE OF THE BONE TRACKERS. THERE WAS NO INDICATION IN THE LOGS THAT A SOFTWARE DEFECT OR ANOMALY CAUSED OR CONTRIBUTED TO THE OBSERVED ERROR. A FIELD SERVICE ENGINEER WAS ONSITE TO INVESTIGATE THE ROBOT. THE ENGINEER OBSERVED THAT THE CUTS WERE OFF. THE FSE REPLACED THE STARC CARD, CHANGED THE GREEN HSDK TO CONTROLLER CABLE WITH A RED ONE, AND REPLACED THE UMBILICAL CABLE. A PREVENTATIVE MAINTENANCE ON THE UNIT WAS PERFORMED. THE UNIT PASSED ALL FUNCTIONAL TESTS/VERIFICATIONS AND WAS CLEARED FOR CLINICAL USE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. CONTRIBUTING FACTORS INCLUDE: RESECTIONS PERFORMED WHILE IN COLLABORATIVE MODE MOVEMENT/CHANGE OF ORIENTATION OF THE BASE TRACKER MALFUNCTIONING CAMERA HARDWARE. PER SECTIONS 11.3 AND 11.4 OF THE ROSA KNEE USER MANUAL AND SURGICAL TECHNIQUE, RESECTIONS SHOULD BE PERFORMED WHILE PINNED IN STATIONARY MODE. 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": "338915969", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "366323981", "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: B5; G2; G3; H2; H10. 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": "366323982", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT HAS BEEN REPORTED THROUGH A MEDWATCH RECEIVED FROM THE FDA ALLEDGING OCCURANCES OF INACCURATE CUTS AND INCORRECT PLACEMENT OF IMPLANTS RESULTING IN PATIENT INJURIES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE." }, { "mdr_text_key": "319278136", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "319278137", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THERE WAS AN OVER RESECTION OF THE DISTAL FEMORAL CUT THROUGH CUTTING IN COLAB MODE WITH ROSA. OVER RESECTED BY 6MM. SMALL FRAGMENT SCREWS USED TO DISTALIZE FEMORAL IMPLANT. NO ADDITIONAL INFORMATION." } ], "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": "12/15/2023;03/20/2025" } ] }