MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM +8.0

Catalog Number	400-03-404
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to instability.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2023-00066; 400-03-402, 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: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM +8.0
• 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: 24264700
• Report Number: 1644408-2026-00177
• Device Sequence Number: 15957967
• Product Code: LZO
• UDI-Device Identifier: 00888912023313
• UDI-Public: 00888912023313
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/04/2026

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
• Device Catalogue Number: 400-03-404
• Device Lot Number: 874B1190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2022
• 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: 495-00-065 LOT: 539U1168.; 495-17-170 LOT: 579U1041.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male