{ "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": "0009617840-2022-00020", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220506", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20220412", "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": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "BE", "manufacturer_contact_area_code": "574", "date_added": "20220506", "manufacturer_contact_f_name": "CHRISTINA", "device_date_of_manufacturer": "20210418", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1280740", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220506", "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": "N/A", "other_id_number": "", "device_availability": "No", "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": "07/22/2022", "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": "20220506", "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": "20220727", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "14307486", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220412", "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": "294658605", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A TKA ROBOTIC ASSISTED SURGERY THE POSTERIOR RESECTION WAS 4.5MM MORE THAN PLANNED ON BOTH SIDES, RESULTING IN AN UNEQUAL BALANCE BETWEEN EXTENSION AND FLEXION AND THE USE OF A THICKER POLY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "294658606", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT :(B)(4). SAME/SIMILAR TO PRODUCT 510(K): K182964. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN BELGIUM. 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": "331400654", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO ADDITIONAL INFORMATION ON THE REPORTED EVENT." }, { "mdr_text_key": "331400675", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE ROSA KNEE SYSTEM LOG FILES AND PICTURES OF THE CALIPERED VALIDATION AND TRACKER POSITIONING WERE SENT BACK FOR INVESTIGATION. A SUBJECT MATTER EXPERT (SME) PERFORMED AN ANALYSIS. THE LOGS COULD NOT DIRECTLY CONFIRM THE REPORTED EVENT THAT THE POSTERIOR FEMUR WAS OVER-RESECTED BECAUSE THE 4-IN-1 CUT WAS NOT VALIDATED WITH ROSA. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS AND THROUGH CONTACT WITH THE SURGICAL REP: THE FINAL FEMORAL IMPLANT SIZE WAS 9, WHICH IS ALSO THE FEMORAL IMPLANT SIZE USED IN ROSA PLANNING. THEREFORE, IT APPEARS THAT THE ALLEGED POSTERIOR OVER-RESECTION HAD NO IMPACT ON THE IMPLANT SIZE. THE INITIAL FLEXION GAPS DID NOT APPEAR EXCESSIVELY OVER-ESTIMATED. THE VALIDATION TOOL FORK WAS DISMOUNTED AND RE-MOUNTED BETWEEN THE POSTERIOR CONDYLE POINTS ACQUISITION AND THE TIBIA PROXIMAL CUT VALIDATION (SINCE THE DISTAL FEMUR WAS VALIDATED IN BETWEEN). PICTURES SHOWING CALIPER MEASURES WERE PROVIDED AND INDICATE 11MM ON THE LATERAL SIDE AND MEDIAL RESECTION OF 14.5MM. PLANNING WAS 7.0MM ON THE LATERAL SIDE AND 10MM ON THE MEDIAL SIDE. THE LANDMARKS POSITIONS WERE NOT MARKED ON THE BONE. THEREFORE, IT CANNOT BE VERIFIED THAT THE SAME REFERENCE POINTS WERE USED FOR THE CALIPER MEASUREMENTS VERSUS THOSE USED BY ROSA. FLAT CALIPERS WERE USED. THIS TYPE OF CALIPER ALWAYS USES THE WIDEST PART OF THE RESECTION REGARDLESS OF WHERE THE LANDMARKS WERE POSITIONED (COMPARED TO A POINTY CALIPER THAT MEASURES THE DIFFERENCE BETWEEN 2 SPECIFIC POINTS). BASE TRACKER¿S POSITION AND ORIENTATION IN THE CAMERA¿S EYE CHANGED SLIGHTLY BETWEEN THE SIX-POINT REGISTRATION AND THE FIRST TIBIA CUT ATTEMPT. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE DHR IDENTIFIED NO DEVIATION AND/OR ANOMALIES RELATED TO THE REPORTED COMPLAINT EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THROUGH REASSESSMENT OF THIS EVENT, IT WAS IDENTIFIED AS BEING REPORTED IN ERROR. REPORTABILITY IS BASED ON HARM/INTERVENTION REQUIRED AND NOT A SPECIFIC RESECTION LEVEL. NO PATIENT IMPACT, MEDICAL INTERVENTION, OR SURGICAL INTERVENTION WAS REPORTED FOR THIS EVENT; THEREFORE, THE EVENT DOES NOT MEET THE REQUIREMENTS FOR A SERIOUS INJURY/ADVERSE EVENT AND IS CONSIDERED NOT REPORTABLE. 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." } ], "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": "07/28/2022" } ] }