MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; DISC ULNA 3X75MM RT W/ E+ BRNG

Catalog Number	540-63-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to unknown reason.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
The agent reported "(reason is unknown.Ref (b)(4) stated 2nd stage revision, no information was provided about the 1st stage to remove the affected items.)".The previous surgery and the surgery detailed in this event occurred 1 year and 1 month apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Note: pc form, primary surgery d-ticket and revision surgery d-ticket were not available.

• Brand Name: DJO SURGICAL
• Common Device Name: DISC ULNA 3X75MM RT W/ E+ BRNG
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 21947124
• Report Number: 1644408-2025-00566
• Device Sequence Number: 9056315
• Product Code: JDC
• UDI-Device Identifier: 00190446254386
• UDI-Public: 00190446254386
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K013042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 540-63-075
• Device Lot Number: 821W1042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 540-00-000 LOT: 933Y1122.; 540-44-100 LOT: 949Y1023.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female