MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 32C

Catalog Number	941-01-32C
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, patient had a hip done ~6mo ago.Came in with a dislocation and required revision.Female 66.Complaint has been evaluated and is similar to report number 1644408-2023-00307; 941-01-36h, s803 - dislocation, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery due to dislocation.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 32C
• 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: 25616350
• Report Number: 1644408-2026-01232
• Device Sequence Number: 9012232
• Product Code: LPH
• UDI-Device Identifier: 00190446309451
• UDI-Public: 00190446309451
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/24/2026

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: 941-01-32C
• Device Lot Number: 591Z1142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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: 400-03-321 LOT. 860B1295.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female