MAUDE Adverse Event Report: ENCORE MEDICAL, L.P DJO SURGICAL; LINER, ACETABULAR, FMP CONSTRAINED 28XMP9

Catalog Number	436-28-009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the device will not be returned; therefore, an evaluation cannot be performed.Any new information received will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient required revision surgery due to poly wear.

• Brand Name: DJO SURGICAL
• Common Device Name: LINER, ACETABULAR, FMP CONSTRAINED 28XMP9
• 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: 23100889
• Report Number: 1644408-2025-01362
• Device Sequence Number: 18487523
• Product Code: KWZ
• UDI-Device Identifier: 00888912085731
• UDI-Public: 00888912085731
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K023794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 09/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 436-28-009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 68 YR
• Patient Sex: Male