MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD42

Catalog Number	952-28-42F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection.
Additional Manufacturer Narrative
The agent reported revision surgery due to the patient had an infection, this was not a revision because of product.The surgeon replaced our product as a precaution from potential bacteria.Complaint has been evaluated and is similar to report number 1644408-2023-00209; 952-28-42f, s808 - infection, 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: EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD42
• 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: 25150948
• Report Number: 1644408-2026-01013
• Device Sequence Number: 21520120
• Product Code: LPH
• UDI-Device Identifier: 00190446673200
• UDI-Public: 00190446673200
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2026

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: 952-28-42F
• Device Lot Number: 2225A1133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Female