{ "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": "0988", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WARSAW", "manufacturer_contact_address_1": "700 ORTHOPAEDIC DR.", "manufacturer_contact_pcity": "30355268", "event_type": "Injury", "report_number": "1818910-2022-07286", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220422", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20220404", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46581", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "3035526892", "noe_summarized": "1", "manufacturer_contact_l_name": "KARBERG", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "465810988", "manufacturer_g1_state": "IN", "reporter_country_code": "AS", "manufacturer_contact_area_code": "303", "date_added": "20220422", "manufacturer_contact_f_name": "KATE", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1771656", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220422", "brand_name": "VELYS SAW BLADE", "generic_name": "INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT", "manufacturer_d_name": "DEPUY IRELAND - 9616671", "manufacturer_d_address_1": "LOUGHBEG RINGASKIDDY CO.", "manufacturer_d_address_2": "", "manufacturer_d_city": "CORK", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "4515-70-000", "catalog_number": "451570000", "lot_number": "", "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": "10603295519140", "udi_public": "10603295519140", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/06/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "0988", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "3035", "patient": [ { "patient_sequence_number": "1", "date_received": "20220422", "sequence_number_treatment": [ "ATTUNE PS FEM RT SZ 4 NAR CEM" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20220422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "14186364", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220405", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "46581", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "DEPUY ORTHOPAEDICS INC 1818910", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "289863914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "289863915", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON STARTED VELYS RAS ATTUNE PS PRIMARY KNEE AFTER COMPLETION OF ALL INITIALIZATION, CALIBRATION AND DRAPING AS PER THE IFU. NATURAL JOINT ASSESSMENT AND PLANNING WAS THEN COMPLETED AND THE SURGEON CHOSE TO PERFORM A 2 DEGREE VARUS CUT ON THE TIBIA. THE KNEE WAS POSITIONED WITH 'Z' RETRACTORS PLACED MEDIAL AND LATERAL TO PROTECT THE COLLATERAL LIGAMENTS. AFTER FINISHING THE CUT WITH AN OSTEOTOME THE SENSOR TENSOR WAS THEN USED TO CHECK BALANCE WITH THE ACCUBALANCE GRAPH. IT WAS THEN NOTED AN UNEXPECTED INCREASE IN MEDIAL LAXITY RELATIVE TO THE LATERAL COMPARTMENT. AFTER FURTHER ASSESSMENT IT WAS IDENTIFIED THAT THE MCL WAS DAMAGED AND NEED REPAIR WITH FIBREWIRE. THIS WAS COMPLETED AND THE FEMORAL CUTS WERE COMPLETED WITH NAVIGATION. THE REST OF THE CASE PROCEEDED WITHOUT FURTHER DELAY OR INCIDENT. DOE: (B)(6) 2022." }, { "mdr_text_key": "329332114", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THERE WAS A DELAY OF 10 MINUTES." }, { "mdr_text_key": "329332115", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "700 ORTHOPAEDIC DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "465810988", "manufacturer_contact_exchange": "303", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/09/2022" } ] }