MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 75MM

Catalog Number	495-00-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to dislocation and loosening.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2022-00471; (b)(4) - device loosening, (b)(4) - dislocation, revision surgery; surgical - quality complaints.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: EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 75MM
• 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: 22181163
• Report Number: 1644408-2025-00777
• Device Sequence Number: 18289783
• Product Code: KWZ
• UDI-Device Identifier: 00190446153825
• UDI-Public: 00190446153825
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/10/2025

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: 495-00-075
• Device Lot Number: 541U1090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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: 400-03-282 LOT: 858B1279; 952-28-46H LOT: 2227A1055
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female