MAUDE Adverse Event Report: ENCORE MEDICAL, L.P DJO SURGICAL; EXPRT REVISION HIP, LATERAL OFFSET PROXIMAL BODY, 65MM

Catalog Number	495-01-065
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2025-01138; 495-01-075, s800 - revision surgery, 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
It was reported that an acetabular revision was performed on a medacta cup.Surgeon elected to remove the proximal body of a well-fixed exprt hip femoral stem to gain access to the cup.A new proximal body and femoral head were implanted.No issues were reported with the enovis components.

• Brand Name: DJO SURGICAL
• Common Device Name: EXPRT REVISION HIP, LATERAL OFFSET PROXIMAL BODY, 65MM
• 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: 23100887
• Report Number: 1644408-2025-01349
• Device Sequence Number: 9225970
• Product Code: KWZ
• UDI-Device Identifier: 00190446153849
• UDI-Public: 00190446153849
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/18/2025

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 Expiration Date: 05/23/2023
• Device Catalogue Number: 495-01-065
• Device Lot Number: 545U1266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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: 402-03-281 LOT CODE 6110951.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male