{ "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": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "700 ORTHOPAEDIC DR.", "manufacturer_contact_pcity": "90838635", "event_type": "Injury", "report_number": "1818910-2026-12408", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20260721", "manufacturer_address_2": "", "pma_pmn_number": "EXEMPT", "date_of_event": "20260101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46581", "reporter_occupation_code": "", "manufacturer_contact_plocal": "9083863534", "noe_summarized": "1", "manufacturer_contact_l_name": "BELLO", "source_type": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260721", "manufacturer_contact_f_name": "ELBA", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "218502", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260721", "brand_name": "VELYS ARRAY DRILL PIN 125X4 MM", "generic_name": "ORTHOPEDIC MANUAL SURGICAL INSTRUMENT", "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": "", "catalog_number": "451570005", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LXH", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Manual Surgical Instrument", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/23/2026;08/10/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260811", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bone Fracture(s)", "Limb Fracture" ] } ], "distributor_city": "", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "25894144", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260705", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "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": "408241777", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON BELIEVES FRACTURE OF A DISTAL FEMUR MAY HAVE BEEN CAUSED BY BICORTICAL VELYS ARRAY PINS CAUSING STRESS RISER. HE MENTIONED THAT HE WOULD PLAN TO PLACE PINS MORE DISTAL AND UNICORTICAL AS PER VELYS RAS STANDARD PIN PLACEMENT. ONE PATIENT TREATED NON OPERATIVELY, ONE PATIENT TREATED WITH RETROGRADE NAIL. NO OTHER INFORMATION CURRENTLY AVAILABLE, NO LOT NUMBERS ARE AVAILABLE. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. J&J EQUIPMENT INCLUDED ALL INSTRUMENTS, IMPLANTS AND DISPOSABLE NECESSARY TO COMPLETE A CEMENTLESS ATTUNE PRIMARY KNEE WITH THE VELYS ROBOT. WAS THERE ANY REPORTED PATIENT OR USER HARM? UNKNOWN. WAS THERE A SIGNIFICANT DELAY? NO." }, { "mdr_text_key": "408241778", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46581", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2026;08/11/2026" } ] }