MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; INSERT, REVISION EXPRT, SZ A X 12MM, E-PLUS

Model Number	315-0A-712
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number cc-00527652_1644408-2026-00325; 315-0c-717, s800 - revision surgery, 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
Poly swap to thicker insert due to hyperextension.

• Brand Name: DJO SURGICAL
• Common Device Name: INSERT, REVISION EXPRT, SZ A X 12MM, E-PLUS
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 25445759
• Report Number: 1644408-2026-01118
• Device Sequence Number: 20265572
• Product Code: JWH
• UDI-Device Identifier: 00888912113908
• UDI-Public: 00888912113908
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/09/2026

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 Expiration Date: 05/21/2026
• Device Model Number: 315-0A-712
• Device Lot Number: 003R1041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2021
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female