{ "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": "57452603", "event_type": "Injury", "report_number": "0009617840-2025-00010", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250325", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20250227", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745260384", "noe_summarized": "1", "manufacturer_contact_l_name": "RAPSAVAGE", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "AS", "manufacturer_contact_area_code": "574", "date_added": "20250325", "manufacturer_contact_f_name": "JENNIFER", "device_date_of_manufacturer": "20230913", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "548860", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250325", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "20-8020-100-26", "lot_number": "1.4.2.5", "other_id_number": "", "device_availability": "Yes", "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": [ "Computer Software Problem", "Incorrect Measurement", "Computer Software Problem", "Incorrect Measurement" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/25/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250912", "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": "20250325", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "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": "20250702", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "21686422", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250227", "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": "366563837", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). G2 FOREIGN: AUSTRALIA. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "366563838", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THERE WAS OVER RESECTION ON BOTH THE DISTAL FEMORAL AND PROXIMAL TIBIAL RESECTIONS, WITH A NET OVER RESECTION OF 4MM. THE CALIPER OF BONE MATCHED VALIDATED CUTS. PLANNED POLY WAS 10MM, RESULTING IN 13MM POLY WITH ADDITIONAL SOFT TISSUE RELEASES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE." }, { "mdr_text_key": "377775072", "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": "377775073", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, D4 LOT NUMBER/SOFTWARE VERSION, G1, G3, G6, H1, H2, H3, H4, H6, AND H11 CORRECTED: H6 DEVICE CODE. THE INVESTIGATION LOGS PROVIDED WERE ANALYZED BY A SUBJECT MATTER EXPERT (SME). THE LOGS PROVIDED FOR INVESTIGATION CONFIRMED THE REPORTED EVENT OF OVER RESECTION ON BOTH THE DISTAL FEMORAL AND PROXIMAL TIBIAL RESECTIONS REQUIRING A THICKER POLYETHYLENE INSERT THAN PLANNED. THE FOLLOWING COULD BE SEEN IN THE LOGS: BOTH SAVED DISTAL VALIDATIONS SHOWED AN OVER-RESECTION OF 1.5M TO 2.0MM. THE SAVED PROXIMAL VALIDATION SHOWED AN OVER-RESECTION OF 1.5MM MEDIALLY AND 2.0MM LATERALLY. THE FINAL IMPLANT CONFIRMATION SHOWED A 13MM POLYETHYLENE THICKNESS. THE VALIDATIONS FOR THE DISTAL AND PROXIMAL CUTS DEVIATED FROM PLAN BY 1.5 TO 2.0MM ONLY ONE VALIDATION WAS SAVED FOR THE PROXIMAL RESECTION. THERE WAS NO SIGNIFICANT CHANGE IN THE RELATIONSHIP BETWEEN THE CAMERA AND THE BASE REFERENCE DURING THE PROCEDURE. 6-PTS REGISTRATION PASSED ON THE FIRST ATTEMPT. CUT GUIDE CHECKPOINT PASSED ON THE FIRST ATTEMPT. LIVE CUT VALUES WERE AVAILABLE THROUGHOUT THE DISTAL STATIONARY MODE AND REMAINED WITHIN 0.6MM/DEGREES OF THEIR TARGETS. WHEN THE VALIDATION TOOL WAS VISIBLE, LIVE CUT VALUES DIPPED BY 1.0 TO 1.4MM UNDER TARGET. DURING THE TIBIA FLOW, THE LIVE CUT VALUES WERE UNAVAILABLE FOR A SHORT PERIOD OF TIME. PRIOR TO THIS, THE LIVE CUT VALUES REMAINED WITHIN 0.6MM/DEGREES OF THEIR TARGET. AFTER THE VALUES RETURNED, THE LIVE CUT VALUES WERE UNDER TARGET BY 1.9MM ON THE MEDIAL SIDE AND 1.7MM ON THE LATERAL SIDE. FROM THIS POINT ON, UNTIL THE END OF THE STATIONARY MODE, LIVE CUT VALUES REMAINED, ON AVERAGE, 0.5MM UNDER TARGET. PHYSICAL AND TECHNICAL EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE). THE FSE PERFORMED A PLANNED SOFTWARE UPDATE. ALL TESTS PASSED AS PER TECHNICAL DOCUMENTATION AND THE ROSA PLATFORM IS OPERATIONAL FOR CLINICAL USE. THE SERIAL NUMBER WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE SERVICING/MAINTENANCE PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED; THEREFORE, IT IS NOT EXPECTED THAT THE SERVICING/MAINTENANCE PROCESS CONTRIBUTED TO THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON THE INFORMATION AVAILABLE. HOWEVER, THERE WAS NO INDICATION IN THE LOGS THAT A SOFTWARE DEFECT OR ANOMALY CAUSED OR CONTRIBUTED TO THE OBSERVED ERROR. ALL VALIDATIONS WERE WITHIN THEIR TARGET, WHICH SHOWS THE SYSTEM WORKED PER SPECIFICATION. THE SYSTEM RESPONDED AS EXPECTED AND THE VALIDATIONS WERE WITHIN THEIR TARGETS. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH 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": "07/02/2025" } ] }