{ "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": "0009617840-2023-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230508", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20230410", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "901", "date_added": "20230508", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20220427", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1901297", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230508", "brand_name": "ROSA KNEE ROBOTIC UNIT 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": "20-8020-110-01", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00889024511170", "udi_public": "(01)00889024511170(11)220427", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "KY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/03/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250727", "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": "20230508", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230706", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "16885277", "removal_correction_number": "NI", "number_devices_in_event": "", "date_manufacturer_received": "20230410", "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": "335951962", "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 UPDATED: G3; H2; H3; H6. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE), AND CONFIRMED THE APPEARANCE OF UNKNOWN ROBOTIC ERRORS THAT COULD NOT BE RESOLVED BY MULTIPLE RESTARTS. A LOG INSPECTION DISCOVERED A DISCONNECTION OF THE FORCE TORQUE SENSOR FROM THE ARM RELATED TO THE CABLE. THE FSE DECIDED TO REPLACE THE F/T SENSOR CABLE WITH ONE FROM A DEMO UNIT, AND THE ERRORS WERE RESOLVED. THE FSE WENT ON TO REPLACE THE F/T SENSOR AS WELL AND PERFORMED AN ARM ACCURACY AND APPLICATIVE TEST TO ENSURE PROPER FUNCTION. THE UNIT WAS FULLY OPERATIONAL AFTER REPAIRS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE DISCOVERED. WITH THE INFORMATION CURRENTLY AVAILABLE, A ROOT CAUSE FOR THE MALFUNCTION OF THE FORCE TORQUE SENSOR AND THE FORCE SENSOR CABLE RESULTING IN DISCONNECTIONS CANNOT BE DEFINITIVELY DETERMINED. 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." }, { "mdr_text_key": "335951963", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO ADDITIONAL INFORMATION ON THE REPORTED EVENT." }, { "mdr_text_key": "314720617", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, ROBOTIC UNIT REMAINS AT HOSPITAL AND WILL BE EVALUATED BY ENGINEER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : ROBOTIC UNIT REMAINS ON SITE." }, { "mdr_text_key": "314720619", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED PATIENT UNDERWENT AN INITIAL ROSA LEFT KNEE ARTHROPLASTY. DURING THE CASE, ROSA GAVE A CONSTANT \"FORCE COLLISION ERROR DETECTED\" WITH NO FORCE ON THE ARM. SUBSEQUENTLY, CASE WAS CANCELED AND PATIENT WAS WOKEN UP FROM ANESTHESIA. CASE WAS RESCHEDULED. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT." } ], "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": "07/07/2023" } ] }