{ "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": "57452737", "event_type": "Injury", "report_number": "0009617840-2022-00017", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220406", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20220311", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745273773", "noe_summarized": "1", "manufacturer_contact_l_name": "ARNT", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "H3C 2N6", "manufacturer_g1_state": "", "reporter_country_code": "SN", "manufacturer_contact_area_code": "574", "date_added": "20220406", "manufacturer_contact_f_name": "CHRISTINA", "device_date_of_manufacturer": "20210107", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1581458", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220406", "brand_name": "ROSA RECON PLATFORM 220V", "generic_name": "N/A", "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": "20-8020-100-26", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "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 Measurement", "Incorrect Measurement" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/26/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20220406", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "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": "20220728", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "14022594", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220311", "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": "331867726", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORTED EVENT WAS CONFIRMED. INVESTIGATION LOG FILES WERE PROVIDED TO THE PRODUCT SURVEILLANCE TEAM FOR FURTHER EVALUATION AND REVIEWED BY A SUBJECT MATTER EXPERT. THE REPORTED ISSUE NOT BEING CONFIRMED TO BE PRIOR TO ITS FIRST USE SUGGEST IT IS UNLIKELY TO BE THE RESULT OF A MANUFACTURING, INSTALLATION, OR MAINTENANCE/SERVICING DEFICIENCY. AS SUCH, A MANUFACTURING DHR REVIEW WAS NOT PERFORMED. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED THROUGH REASSESSMENT OF THIS EVENT, IT WAS IDENTIFIED AS BEING REPORTED IN ERROR. REPORTABILITY IS BASED ON HARM/INTERVENTION REQUIRED AND NOT A SPECIFIC RESECTION LEVEL. NO PATIENT IMPACT, MEDICAL INTERVENTION, OR SURGICAL INTERVENTION WAS REPORTED FOR THIS EVENT; THEREFORE, THE EVENT DOES NOT MEET THE REQUIREMENTS FOR A SERIOUS INJURY/ADVERSE EVENT AND IS CONSIDERED NOT REPORTABLE. 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": "331867727", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO ADDITIONAL INFORMATION ON THE REPORTED EVENT." }, { "mdr_text_key": "288691953", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT (B)(4). COUNTRY OF ORIGIN SINGAPORE, SAME OR SIMILAR TO K182964. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED." }, { "mdr_text_key": "288691954", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TKA AN OVER-RESECTION OF 5-6MM OCCURRED ON THE TIBIA. DUE TO THIS OVER-RESECTION, A 14MM ARTICULATING SURFACE WAS USED INSTEAD OF A 10MM SURFACE. OTHER THAN THAT DEVIATION IN ARTICULAR SURFACE, THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION REGARDING THIS 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": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/01/2022" } ] }