MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; INSERT, 3D SIZE10 X 9MM R DCM

Catalog Number	392-09-610
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to poly wear.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2023-00028; 392-09-608, s805 - wear/excessive wear, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: INSERT, 3D SIZE10 X 9MM R DCM
• 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
• MDR Report Key: 24355562
• Report Number: 1644408-2026-00254
• Device Sequence Number: 11949436
• Product Code: JWH
• UDI-Device Identifier: 00888912120203
• UDI-Public: 00888912120203
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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
• Device Catalogue Number: 392-09-610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male