MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; FEMUR, NONPOROUS, 3D, SIZE3, LT

Model Number	233-01-103
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Dr.(b)(6) did the primary left tkr w/legacy old style 3d knee (b)(6) 2017.The patient presented with failed/loose displaced femoral component.Dr.(b)(6) removed the femur, tibia and tibial insert.He implanted the empower revision knee with femoral and tibial cones.
Additional Manufacturer Narrative
See d4 expiration date, h4, h6, h10 and h11 complaint has been evaluated and is similar to report number 1644408-2018-00292; 233-01-110, 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: FEMUR, NONPOROUS, 3D, SIZE3, LT
• 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: 23843663
• Report Number: 1644408-2025-01968
• Device Sequence Number: 9958514
• Product Code: MBH
• UDI-Device Identifier: 00888912111102
• UDI-Public: 00888912111102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/30/2026

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: 11/03/2022
• Device Model Number: 233-01-103
• Device Lot Number: 881A1048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2016
• 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: 323-01-102 (B)(6).; 391-09-703 (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female