MAUDE Adverse Event Report: Encore Medical L.P DJO SURGICAL; AR, SMALL SOCKET INSERT, 36MM SEMI CONSTRAINED Eplus

Catalog Number	509-03-036
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to discomfort.
Additional Manufacturer Narrative
The agent reported, there wasn't really a product problem other than the patient has discomfort and swelling from the initial surgery, about 7 months prior.Age 57 gender male.Complaint has been evaluated and is similar to report number 1644408-2023-00317; 509-03-432, s807 - pain, 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, 36MM SEMI CONSTRAINED 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: 50766717
• Report Number: 1644408-2026-01923
• Device Sequence Number: 9668427
• Product Code: KWS
• UDI-Device Identifier: 00190446257608
• UDI-Public: 00190446257608
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• 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): 09/14/2026

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: 509-03-036
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 508-36-101 Lot. Unknown
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male