{ "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": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "0009617840-2020-00001", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200127", "manufacturer_address_2": "", "pma_pmn_number": "K19074", "date_of_event": "20191118", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20200127", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "97756", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200127", "brand_name": "ROSA KNEE PLATFORM GB PL G", "generic_name": "INSTRUMENT, 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": "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": "20-8020-100-12", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00889024511286", "udi_public": "0889024511286", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect Measurement", "Output Problem", "Positioning Problem", "Incorrect Measurement", "Output Problem", "Positioning Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/04/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200127", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200305", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9632853", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200114", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315337665", "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": "315337666", "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: B4; B5; G4; G7; H1; H2; H3; H6. INDEPENDENT ASSESSMENT OF THE POST OP IMAGES CONFIRMS THE REPORTED EVENT. HOWEVER, THE ASSESSMENT REVEALED A GRADE 1 VALGUS MEASURED AT 5 DEGREES (GRADE 1 < 10 DEGREES). THE FEMORAL AND TIBIAL COMPONENTS RELATIVE TO THE MECHANICAL AXIS WERE 92 AND 94 DEGREES, RESPECTIVELY. THE ROSA KNEE SYSTEM SOFTWARE APPLICATION LOG FILES WERE SENT BACK FOR INVESTIGATION. INVESTIGATION OF THE LOG FILES BY A SOFTWARE SME REVEALED THE FOLLOWING: NO REGISTRATION FAILS WERE ENCOUNTERED DURING LANDMARKING OF THE IMAGE BASED CASE, THUS INDICATING THAT LANDMARK ACQUISITION WAS PERFORMED CORRECTLY; CUT VALIDATION VALUES WERE CLOSE TO 0 DEGREES (FEMUR 0.2VARUS, TIBIA 0.4VARUS) AND CORRESPOND TO THE INTRA-OPERATIVELY PLANNED CUTS; FINAL KNEE STATE IN EXTENSION WAS SYMMETRICAL AT AROUND 0 DEGREE HKA. FURTHERMORE, THE ROSA KNEE SYSTEM WAS ASSESSED FOR ROBOTIC ARM ACCURACY, CAMERA ACCURACY AND APPLICATIVE TEST AND FOUND TO BE ACCURATE AND FUNCTIONAL. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION CONFIRMED THAT THE ROSA KNEE SYSTEM WAS CONFORMING TO SPECIFICATIONS AS NO ISSUES WERE FOUND DURING THE EVALUATION. ADDITIONALLY, NO ISSUES WERE IDENTIFIED DURING THE LOG FILES INVESTIGATION. THEREFORE, THE REPORTED EVENT IS NOT CONSIDERED TO HAVE BEEN CAUSED BY A MALFUNCTION OF THE ROSA KNEE SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT 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": "189995556", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). AGE: (B)(6). REPORT SOURCE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS REMAINS AT THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "189995557", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PLANNED OUTCOME AND VALIDATED CUT SHOWED 0 DEGREES VARUS/VALGUS. HOWEVER, POST-OP X-RAYS SHOW A GRADE 2 VALGUS. IT WAS NOTED THAT THE PATIENT WAS VARUS PRE-OP." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/06/2020" } ] }