{ "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": "0009617840-2022-00029", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20221215", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20220728", "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": "AS", "manufacturer_contact_area_code": "901", "date_added": "20221215", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20200520", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1439145", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20221215", "brand_name": "ROSA RECON PLATFORM 220V", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "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": "H3C 2", "manufacturer_d_zip_code_ext": "N6", "manufacturer_d_country": "CA", "manufacturer_d_postal_code": "H3C 2N6", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "20-8020-100-26", "lot_number": "NI", "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", "Adverse Event Without Identified Device or Use Problem", "Incorrect Measurement", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/05/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250728", "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": "20221215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20230406", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "15987641", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221121", "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": "305525099", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THE SURGEON QUESTIONED THE ALIGNMENT ON POST OP X-RAY GIVEN THE PLANNED AND VALIDATED CUTS MEASURED DO NOT CORRELATE. PLANNED FOR NEUTRAL TO SLIGHT VALGUS KNEE OVERALL, STARTED AT 18 DEG VALGUS. VALIDATED CUTS SUGGEST WE SHOULD HAVE ENDED UP AT NEUTRAL OR CLOSE TO HOWEVER ON POST OP X-RAYS HAVE ENDED AT 10 DEG VARUS. THE PATIENT HAS ALSO REPORTED SIGNS OF PAIN AND INSTABILITY. THE PATIENT IS BEING CONSIDERED FOR A REVISION. NO ADDITIONAL INFORMATION." }, { "mdr_text_key": "305525100", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). REPORT SOURCE: FOREIGN: COUNTRY: AUSTRALIA. 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": "337195759", "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, B5, E1, G3, H2, H3, H4, H6. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. REVIEW OF THE PROVIDED X-RAYS IDENTIFIED MISPOSITIONING OF THE TIBIAL IMPLANT (LATERAL ORIENTATION OF THE DISTAL TIP OF THE TIBIAL COMPONENT), WHICH COULD RESULT IN INSTABILITY AND/OR PAIN. HOWEVER, THE POSTOPERATIVE VARUS ALIGNMENT OF THE KNEE WAS NOTED AS EXTREMELY SUBTLE, AND THERE WAS NO OBVIOUS ROTATION OF THE LEG OBSERVED IN THE X-RAYS. A SUBJECT MATTER EXPERT (SME) PROVIDED ANALYSIS OF THE INVESTIGATION LOGS FOR THIS CASE. THE SME DID NOT IDENTIFY ANY SOFTWARE OR HARDWARE ANOMALY THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE VARUS KNEE ALIGNMENT. THE FOLLOWING FACTS WERE IDENTIFIED: THE PROVIDED LOGS CONFIRM A VALIDATED LEG ALIGNMENT OF 0.6 DEGREES VALGUS. LOGS SHOW NO INDICATIONS OF INACCURATE CUTS RELATIVE TO THE LANDMARKED MECHANICAL AXES. LOGS SHOW NO INDICATIONS OF LANDMARKING DEVIATING FROM THE TRUE BONE ANATOMY. LOGS SHOW NO INDICATIONS THAT A BONE REFERENCE/TRACKER MOVEMENT COULD HAVE AFFECTED THE CUTS AND FINAL KNEE EVALUATION RESULTS COMPARED TO THE INITIAL/INTRAOP KNEE EVALUATIONS. BETWEEN THE END OF THE 6 POINT REGISTRATION AND START OF ARM MOVEMENT IN AUTOMATIC MODE, A MOVEMENT OF 109.4MM WAS RECORDED, LIKELY FROM A MANUAL REPOSITIONING OF THE CAMERA. THIS MOVEMENT CHANGED THE ORIENTATION OF HOW THE BASE TRACKER WAS SEEN BY THE CAMERA BUT IS UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED EVENT. MOVEMENT RESULTING IN INACCURACY WOULD HAVE BEEN IDENTIFIED BY DISCREPANCIES DURING RESECTION VALIDATION. GREAT VARIABILITY WAS OBSERVED IN THE MEDIO-LATERAL (ML) DISTANCE BETWEEN THE TWO BONES DURING THE DIFFERENT SURGERY STEPS (ML DISTANCE GOING FROM NEGATIVE7MM TO PLUS 9MM IN BETWEEN SURGERY STEPS. AND DURING RESECTIONS, FOR A SAME LEG ANGLE, ML DISTANCE CHANGED FROM -5MM TO +7MM BETWEEN TIBIA AND FEMUR RESECTIONS). THIS APPRECIABLE VARIATION IN THE ML DISTANCE CAN INDICATE A LOOSE BONE REFERENCE THAT AFFECTED THE RESECTIONS. HOWEVER THIS IS UNLIKELY BASED ON THE RESULTS OF THE KNEE EVALUATIONS PERFORMED. ADDITIONALLY, PRE-OP IMAGE-BASE E-MANUFACTURING WAS REVIEWED AND CONFIRMED TO BE ACCURATE. A FINAL ANALYSIS BY THE SME CONCLUDED THAT THE LOGS DID NOT CONFIRM OR SUGGEST ANY MALFUNCTION FROM THE ROSA SYSTEM, NOR WERE ANY SOFTWARE ANOMALIES IDENTIFIED. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE) AND COULD NOT CONFIRM THAT THE REPORTED EVENT WAS CAUSED BY ANY ISSUE WITH THE ROSA SYSTEM. THE UNIT PASSED A FULL PREVENTATIVE MAINTENANCE AND SHOWED NO SIGNS OF HARDWARE DEFECTS OR SOFTWARE ISSUES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE UNIT WAS CLEARED FOR CLINICAL USE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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": "337195760", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." } ], "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": "04/17/2023" } ] }