{ "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": "", "manufacturer_contact_t_name": "MS.", "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": "1818910-2025-21991", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20251216", "manufacturer_address_2": "", "pma_pmn_number": "EXEMPT", "date_of_event": "20251202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46581", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9083863534", "noe_summarized": "1", "manufacturer_contact_l_name": "BELLO", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "908", "date_added": "20251216", "manufacturer_contact_f_name": "ELBA", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1864782", "implant_date_year": "2025", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20251216", "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": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "10603295519096", "udi_public": "(01)10603295519096", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/12/2026;03/02/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260427", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9083", "patient": [ { "patient_sequence_number": "1", "date_received": "20251216", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Osteopenia/ Osteoporosis", "Limb Fracture", "Osteopenia/ Osteoporosis", "Limb Fracture" ] } ], "distributor_city": "", "date_report": "20251216", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "23818948", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251203", "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": "395727788", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿POSTOP (2.5 WEEKS) FEMORAL FRACTURE AFTER VRAS TKA PROCEDURE. FEMALE PATIENT, LIGHT OSTEOPOROSIS. THE FRACTURE OCCURRED WHEN PATIENT STOOD UP FROM A SEATED POSITION 2.5 WEEKS POST OP. AND SURGEON THINKS THIS IS DUE TO THE HOLES OF THE VELYS ARRAY PINS¿ THE VELYS ARRAY DRILL PIN 125X4 MM WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE RADIOGRAPHIC IMAGES SHOW A SUPRACONDYLAR PERIPROSTHETIC FRACTURE. HOWEVER, DUE TO THE IMAGE QUALITY AND THE LIMITED EVIDENCE PROVIDED, IT IS NOT POSSIBLE TO ASSESS THE PATIENT¿S BONE DENSITY OR DETERMINE THE PRECISE LOCATIONS WHERE THE ARRAY DRILL PIN WERE INSERTED DURING THE PROCEDURE. NONETHELESS, IT IS REASONABLE TO SUSPECT THAT THE OBSERVED FRACTURE MAY HAVE OCCURRED AT OR NEAR THE INSERTION SITES. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE." }, { "mdr_text_key": "394051543", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D6B, D10 (CONCOMITANT). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "387786423", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "387786424", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46581", "manufacturer_contact_exchange": "908", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/13/2026;03/03/2026" } ] }