MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, MULTI HOLE, 56

Catalog Number	940-03-56H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to loosening and instability.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2024-00543; 940-02-50e, s810 - device loosening, 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: EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, MULTI HOLE, 56
• 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: 22538522
• Report Number: 1644408-2025-01002
• Device Sequence Number: 20837539
• Product Code: LPH
• UDI-Device Identifier: 00190446311744
• UDI-Public: 00190446311744
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/17/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 940-03-56H
• Device Lot Number: 817Z1028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: 400-03-281 LOT: 857B1321.; 940-00-020 LOT: 145Z1118.; 940-00-025 LOT: 146Z1238.; 940-00-025 LOT: 146Z1238.; 940-00-025 LOT: 146Z1238.; 940-00-035 LOT: 148Z1205.; 951-01-46H LOT: 2219A1080.; 952-28-46H LOT: 2227A1103.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 91 KG