MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 28MM NEUTRAL

Catalog Number	400-03-282
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - revision of the cup.Removed dm head, dm liner, cup and screws.Put in a zimmer cup and liner, with an enovis head.Unknown reason.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2021-00626; 400-03-283, s800 - revision surgery, 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, 28MM NEUTRAL
• 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: 23712089
• Report Number: 1644408-2025-01831
• Device Sequence Number: 8927285
• Product Code: LZO
• UDI-Device Identifier: 00888912076067
• UDI-Public: 00888912076067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/10/2026

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: 400-03-282
• Device Lot Number: 858B1460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/07/2030
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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: 940-00-025 LOT: 146Z1340; 940-00-025 LOT: 815Z1052; 940-00-030 LOT: 147Z1269; 951-01-42F LOT: 2217A1133; 952-28-42F LOT: 2225A1133
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female