MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; AR, SMALL SOCKET INSERT, 32MM SEMI CONSTRAINED +4 EPLUS

Catalog Number	509-03-432
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to instability / dislocation.
Additional Manufacturer Narrative
The agent reported, instability dislocation.Female 60 yrs.Complaint has been evaluated and is similar to report number 1644408-2022-00706; 508-32-103, s803 - dislocation, revision surgery.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, 32MM SEMI CONSTRAINED +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
• MDR Report Key: 25273196
• Report Number: 1644408-2026-01002
• Device Sequence Number: 9167624
• Product Code: KWS
• UDI-Device Identifier: 00190446257585
• UDI-Public: 00190446257585
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 509-03-432
• Device Lot Number: 954W1351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 506-04-114 LOT. 5031A1182.; 506-04-122 LOT. 5035A1024.; 506-04-122 LOT. 5035A1029.; 508-32-101 LOT. 862C5001.; 508-32-204 LOT. 769P3931.; 533-08-108 LOT. 926W2530D.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female