MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; AR, SMALL SOCKET INSERT, 44MM NEUTRAL +4 EPLUS

Catalog Number	509-02-444
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2021-00364; 508-32-101, s814 - stability, poor joint, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - due to instability.
Additional Manufacturer Narrative
See d2a, d4, d10, g4, h10 and h11 complaint has been evaluated and is similar to report number 1644408-2023-00196; 509-02-436, s814 - stability, poor joint, 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: AR, SMALL SOCKET INSERT, 44MM NEUTRAL +4 EPLUS
• 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: 24173040
• Report Number: 1644408-2026-00139
• Device Sequence Number: 18636771
• Product Code: KWS
• UDI-Device Identifier: 00190446257691
• UDI-Public: 00190446257691
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/10/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 509-02-444
• Device Lot Number: 965W1030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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: 506-03-118 LOT: 832C2530; 506-03-126 LOT: 834C2611; 506-03-126 LOT: 834C2611; 506-03-130 LOT: 835C2573; 508-32-204 LOT: 769P3829; 508-44-101 LOT: 877C1298; 509-02-444 LOT: 965W1030; 533-10-220 LOT: 931W1011
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown