{ "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": "57452737", "event_type": "Injury", "report_number": "0009617840-2022-00019", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220421", "manufacturer_address_2": "", "pma_pmn_number": "K182964", "date_of_event": "20211004", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745273773", "noe_summarized": "1", "manufacturer_contact_l_name": "ARNT", "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": "574", "date_added": "20220421", "manufacturer_contact_f_name": "CHRISTINA", "device_date_of_manufacturer": "20210120", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "605626", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220421", "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": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/31/2022", "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": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20220421", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "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": "20220426", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "14174615", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211014", "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": "294640450", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT: (B)(4). PLEASE NOTE THAT THIS INCIDENT WAS PREVIOUSLY DOCUMENTED UNDER MFR: 0001822565 - 2021 - 03067. THIS INCIDENT IS BEING RESUBMITTED TO MORE ACCURATELY DOCUMENT THE REPORTED EVENT. ALL NECESSARY INFORMATION NEEDED FOR A INVESTIGATION HAS BEEN PROVIDED, THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "294640451", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA WERE 4MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY INSERT (16 MM) WITH NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "329128007", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT : (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SUMMARY: TECHNICAL REVIEW AND PHYSICAL EVALUATION: THE LOG FILE ANALYSIS CONFIRMS THE REPORTED ISSUE. THE VALIDATION VALUES WAS MEASURED ONCE AFTER THE CUT STEP, AND INDICATED AN OVER RESECTION ON THE MEDIAL SIDE AND ON THE LATERAL SIDE. THERE WAS A 55 SECOND INTERRUPTION OF LIVE VALUES WHERE THE TRACKER COULD NOT BE SEEN. WHEN THE LIVE VALUES ARE VISIBLE AGAIN, THE MEDIAL SIDE IS RESECTED 2.1MM MORE THAN PLANNED AND LATERAL SIDE 2.3MM MORE. PREVENTIVE MAINTENANCE AND SOFTWARE UPDATE WAS PERFORMED BY FIELD SERVICE TECHNICIAN ON JAN 24, 2022, SYSTEM PASSED ALL TESTS SUCCESSFULLY, AND NO SOFTWARE APPLICATION OR DEVICE MALFUNCTION WERE NOTED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED DHR REVIEW: REVIEW OF THE DHR IDENTIFIED NO DEVIATION AND/OR ANOMALIES RELATED TO THE REPORTED COMPLAINT EVENT. COMPLAINT HISTORY REVIEW A COMPLAINT HISTORY REVIEW WAS CONDUCTED. THE SEARCH IDENTIFIED NO ADDITIONAL RELEVANT COMPLAINTS REPORTED FOR THIS DEVICE. THE SEARCH IDENTIFIED ELEVEN (11) ADDITIONAL COMPLAINTS REPORTED FOR THE PART # CONCERNED WITHIN ONE (1) YEAR PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT (OCT 14, 2021) AND THEREAFTER FOR THE SAME OR SIMILAR ISSUE. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS PER QI09-03. 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": "329128008", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA WERE 4MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY INSERT (16 MM) WITH NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. 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": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/26/2022" } ] }