{ "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": "0009617840-2021-00026", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220104", "manufacturer_address_2": "", "pma_pmn_number": "K182964", "date_of_event": "20211206", "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": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "901", "date_added": "20220104", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20210606", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1225820", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220104", "brand_name": "ROSA KNEE PLATFORM US PL B", "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": "20-8020-100-01", "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, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/07/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20220104", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220701", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "13156876", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211206", "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": "286653766", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A ROSA TKA SURGERY THE 4-IN-1 CUT WAS NOT ACCURATE AND LED TO AN OVER-RESECTION. THE OVER-RESECTION WAS ENOUGH TO NOTCH THE FEMUR. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "286653767", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED." }, { "mdr_text_key": "330944096", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION FROM THE COMPLETED INVESTIGATION. TECHNICAL REVIEW AND PHYSICAL EVALUATION: THE SYSTEM SOFTWARE LOG FILES ASSOCIATED WITH THE REPORTED EVENT WERE PROVIDED FOR REVIEW. INVESTIGATION OF THE LOG FILES CONFIRMED THE REPORTED EVENT OF RESECTION VALUE DISCREPANCY. ANALYSIS OF THE POSITION OF ROBOT BASE TRACKER IN CAMERA BASE SHOWS A MAJOR DISPLACEMENT BETWEEN 6-POINT REGISTRATION AND POSITIONING FOR THE FIRST CUT (FEMUR DISTAL CUT). SUCH DISPLACEMENT COULD BE REPRESENTATIVE OF A MOVEMENT OF THE CAMERA, OF THE ROBOTIC UNIT, OF THE ROBOT BASE TRACKER OR A COMBINATION OF THE THREE. CONSIDERING THE AMPLITUDE OF THE MOVEMENT, A REPOSITIONING OF THE CAMERA IS MOST LIKELY INVOLVED. THERE WERE NO SOFTWARE DEFECTS OR ANOMALIES IDENTIFIED IN THE LOGS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SYSTEM WAS EVALUATED ONSITE BY A FIELD SERVICE ENGINEER (FSE) DURING PREVENTIVE MAINTENANCE. THE DEVICE WAS CONFIRMED TO BE CONFORMING TO SPECIFICATIONS AND ACCEPTABLE FOR USE. DHR REVIEW: DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS CONDUCTED. THE SEARCH IDENTIFIED FOUR (4) ADDITIONAL COMPLAINTS FOR THE SAME SERIAL/LOT NUMBER THAT WAS FOR THE SAME OR SIMILAR ISSUE. THE SEARCH IDENTIFIED EIGHTEEN (18) ADDITIONAL COMPLAINTS REPORTED FOR THIS DEVICE WITHIN ON (1) YEAR PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT AND THEREAFTER FOR THE SAME OR SIMILAR ISSUE. ROOT CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS." }, { "mdr_text_key": "330944097", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A TKA SURGERY UTILIZING ROBOTIC INSTRUMENTATION THE 4-IN-1 CUT WAS NOT ACCURATE AND LED TO AN OVER-RESECTION. THE OVER-RESECTION WAS ENOUGH TO NOTCH THE FEMUR. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN 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": "07/01/2022" } ] }