{ "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": "0009617840-2024-00009", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240522", "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": [ "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": "20240522", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20240409", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1570148", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240522", "brand_name": "ROSA RECON PLATFORM 110V", "generic_name": "ROBOTIC SURGICAL ARM SYSTEM", "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": "N/A", "catalog_number": "20-8020-100-01", "lot_number": "NI", "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": [ "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": "04/09/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250813", "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": "20240522", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " H" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250416", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "19373639", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240430", "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": "368365899", "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": "368365900", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN XRAY OF THE RESULTING IMPLANTED SHOULDER WAS PROVIDED. THE LOW RESOLUTION PREVENTED ITS REVIEW. PICTURES WERE PROVIDED FOR INVESTIGATION. THE FIRST FOUR PICTURES SHOW THE SCREEN AT DIFFERENT POINTS OF THE PLANNING. THE INTRA OP PICTURE (DPE GLENOID) WAS REVIEWED BY A SUBJECT MATTER EXPERT (SME). THE SME CONFIRMED THAT THE PATIENT ANATOMY SHOWN IN THE PICTURE CONCORDS WITH THE REPORTED EVENT AND THE RECREATION OF THE EVENT FROM THE LOGS. THE INVESTIGATION LOGS PROVIDED WERE ANALYZED BY A SUBJECT MATTER EXPERT (SME). LOGS CONFIRMED THE REPORTED EVENT OF THE PROCEDURE RESULTING IN AN OBLONG HOLE. THE FOLLOWING FACTS WERE OBSERVED IN THE LOGS: - THERE WERE 11 INSTANCES OF CAMERA MOTION CHECKING, WHICH SUGGESTS THE MOVEMENT OF THE CAMERA, ROBOT AND/OR BASE REFERENCE. THE CAMERA MOTION LOG ENTRIES SHOW A MAXIMUM DISPLACEMENT OF 3MM. - AN EXCESSIVE BASE REFERENCE TRACKER MOVEMENT ERROR WAS SEEN, INDICATING A MOVEMENT OF THE CAMERA, ROBOT, AND/OR BASE REFERENCE. - THE MOVEMENT OF TRACKER 9 COULD INVALIDATE THE ROSA REGISTRATION COMPLETED IN THE SETUP FLOW AND COULD IMPACT THE ACCURACY OF THE REAMED HOLE. - MULTIPLE TRACKER 6 VISIBILITY ISSUES WERE OBSERVED DURING THE REAMING FLOW. THERE WAS NO INDICATION IN THE LOGS THAT A SOFTWARE DEFECT OR ANOMALY CAUSED OR CONTRIBUTED TO THE OBSERVED ERROR. 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. 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." }, { "mdr_text_key": "343119373", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). A1: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WILL REMAIN IN THE HEALTH CARE FACILITY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED" }, { "mdr_text_key": "343119374", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE REAMING, THE SURGEON FELT THAT THE REAMER HAD HIT VERY HARD BONE AND STATED THAT THE SCAPULA AND ROBOT VIBRATED A LOT. AFTER REAMING, THE CENTRAL HOLE CREATED BY THE REAMER WAS OBLONG RESULTING IN A BONE GRAFT. THERE IS NO ADDITIONAL 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": "04/17/2025" } ] }