MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; FMP NEUTRAL LINER, 32MM, MP9, HXE-PLUS

Catalog Number	431-32-709
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, general instability.Complaint has been evaluated and is similar to report number 1644408-2025-00695; 431-32-708, 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.

• Brand Name: DJO SURGICAL
• Common Device Name: FMP NEUTRAL LINER, 32MM, MP9, HXE-PLUS
• 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: 25311007
• Report Number: 1644408-2026-00989
• Device Sequence Number: 10511734
• Product Code: OQG
• UDI-Device Identifier: 00888912084659
• UDI-Public: 00888912084659
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K140130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/27/2026

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: 06/07/2019
• Device Catalogue Number: 431-32-709
• Device Lot Number: 651N1034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-323 LOT. 862B1220.; 430-98-056 LOT. 591G1417A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male