{ "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": "0009617840-2019-00003", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190712", "manufacturer_address_2": "", "pma_pmn_number": "K182964", "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", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190712", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "577964", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190712", "brand_name": "ROSA KNEE ROBOTIC UNIT US", "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": "20-8020-110-01", "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": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect Measurement", "Incorrect Measurement" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/12/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20190712", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20191213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8784566", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190618", "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": "150827360", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE." }, { "mdr_text_key": "150827361", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE SURGEON WAS VALIDATING THE TIBIAL CUTS, THE SYSTEM WAS STATING THAT NOT ENOUGH WAS CUT PER THE PLAN AND THE ROD SHOWED BAD ALIGNMENT. THE SURGEON MADE ADDITIONAL CUTS TO BRING THE TIBIA INTO NEUTRAL ALIGNMENT WHEN HE SWITCHED TO CONVENTIONAL INSTRUMENTATION." }, { "mdr_text_key": "311870505", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE REPORTED EVENT COULD NOT BE CONFIRMED; REVIEW OF LOG FILES SHOWS THERE WAS NO DISCREPANCY BETWEEN THE VARUS/VALGUS IN PRE-OPERATIVE PLAN AND VALIDATION FOR ALL THE CUTS PERFORMED WITH ROSA ROBOT SYSTEM AND THERE IS NO EVIDENCE IN THE LOG FILES THAT THE PERCEIVED DISCREPANCIES WERE CAUSED BY A SOFTWARE ISSUE OR SYSTEM MALFUNCTION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED AS THE ISSUE COULD NOT BE CONFIRMED. 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": "311870506", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO ADDITIONAL INFORMATION REPORTED." } ], "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": "12/13/2019" } ] }