{ "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": "0009617840-2025-00007", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250228", "manufacturer_address_2": "", "pma_pmn_number": "K210121", "date_of_event": "20240430", "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": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "901", "date_added": "20250228", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20240409", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2672470", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20250228", "brand_name": "ROSA RECON PLATFORM 110V", "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": "", "catalog_number": "20-8020-100-01", "lot_number": "1.0.0", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "OLO", "device_age_text": "", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20250228", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Extraskeletal ossification", "Extraskeletal ossification" ] } ], "distributor_city": "", "date_report": "20250226", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "21491756", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250130", "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": "364674813", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4) INVESTIGATION OF THE LOG FILES WAS PERFORMED BY A SUBJECT MATTER EXPERT (SME). THE RECONSTRUCTION OF THE SURGICAL SCENE CONFIRMS THE VALIDATION TOOL SHOWED AN INACCURACY OF 6 MM TOWARD THE POSTERIOR. THE SURGEON HAD TO GRAFT THE HOLE AND REAMED AGAIN WITH CONVENTIONAL INSTRUMENTATION TO PREPARE THE CENTRAL HOLE. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: ROSA REGISTRATION AND SCAPULA REGISTRATION, GLENOID SURFACE AND CORACOID BASE WAS PERFORMED SUCCESSFULLY AT FIRST TRIALS WITH ACCEPTABLE RMS VALUES. THERE IS A SIGNIFICANT CAMERA MOVEMENT ON Y BY 10MM AND Z AXES BY 50MM DURING THE SURGERY AFTER THE ROSA REGISTRATION WHICH SUGGESTS THE MOVEMENT OF THE CAMERA, ROBOT AND/OR BASE REFERENCE WITH RESPECT TO THE POSITIONS DURING ROSA REGISTRATION. MOVEMENT AFTER REGISTRATION (WITHOUT RE-ACQUIRING) CAN CREATE AN OFFSET FOR THE REAMING. DURING THE SCAPULA REAMING STEP, A TOTAL OF 18 ERRORS WHICH INCLUDED COMMUNICATION ERRORS, EXCESSIVE BASE REFERENCE TRACKER MOVEMENT, COLLISION, POSITION NOT ACCESSIBLE, AND SINGULARITY ERRORS. ALL THESE ERRORS MAY CONTRIBUTE TO DIFFICULTIES TO ALIGN WITH THE REAMING AXIS. THERE WERE VISIBILITY ISSUES WITH TRACKER 6. THE INACCURACY IN REAMING HOLE MIGHT HAVE BEEN CREATED ALSO BY CONTINUING TO PUSH AND REAM WHEN THE TRACKER WAS NO LONGER VISIBLE. TRACKER 9 LOGS SHOW A MAXIMUM MOVEMENT OF 1.5MM AFTER ROSA REGISTRATION. THIS MOVEMENT COULD IMPACT THE REAMING WORKFLOW ACCURACY. THERE IS NO EVIDENCE TO INDICATE THAT THE ROSA MALFUNCTIONED OR CONTRIBUTED TO THE EVENT. THE CAUSE OF THE MOVEMENT AND ERRORS CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE; THOUGH, THE LOGS DO NOT INDICATE A SOFTWARE ANOMALY ISSUE. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS REVIEW DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THERE IS NO EVIDENCE TO INDICATE THAT THE ROSA MALFUNCTIONED OR CONTRIBUTED TO THE EVENT. THE LOGS DO NOT INDICATE A SOFTWARE ANOMALY ISSUE. THE CAUSE OF THE REAMING INACCURACY AND MOVEMENT AND ERRORS OBSERVED IN THE LOGS CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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": "364674814", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE TIP OF THE REAMER WAS 6MM TOO POSTERIOR COMPARED TO PLAN. THE SURGEON HAD TO GRAFT THE HOLE AND REAMED AGAIN WITH CONVENTIONAL INSTRUMENTATION TO PREPARE THE CENTRAL HOLE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." } ], "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": "" } ] }