{ "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": "0009617840-2022-00008", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220204", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20220111", "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": [ "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": "901", "date_added": "20220207", "manufacturer_contact_f_name": "KRISTEN", "device_date_of_manufacturer": "20210507", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "947331", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220204", "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": "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": "R", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/07/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250801", "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": "20220204", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "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": "20220707", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "CA", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "13451267", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220111", "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": "287036279", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). SAME/SIMILAR TO ROSA UNIT 510(K): 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": "287036280", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE." }, { "mdr_text_key": "331289382", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET COMPLAINT (B)(4). SAME/SIMILAR TO PRODUCT 510(K): K182964. G2: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN AUSTRALIA. THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4, G1-2, G3, G6, H2, H10." }, { "mdr_text_key": "331289383", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE." } ], "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": "07/07/2022" } ] }