MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; EMPOWR REVISION KNEETM REV VVC+ TIBIAL INSERT E+, SZ 5, 14MM

Catalog Number	348-14-705
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection.
Additional Manufacturer Narrative
The agent reported, patients knee was revised less than a month ago and is now infected.Female 65.Complaint has been evaluated and is similar to report number 1644408-2025-00823; 348-16-705, 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 REVISION KNEETM REV VVC+ TIBIAL INSERT E+, SZ 5, 14MM
• 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: 25453228
• Report Number: 1644408-2026-01101
• Device Sequence Number: 15634829
• Product Code: JWH
• UDI-Device Identifier: 00190446722908
• UDI-Public: 00190446722908
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/09/2026

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: 348-14-705
• Device Lot Number: 4681A1005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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: 245-01-105 LOT. 2678A1031.; 245-05-023 LOT. 2739A1027.; 245-05-023 LOT. 2739A1046.; 245-05-045 LOT. 2740A1059.; 346-14-100 LOT. 4624A1006.; 352-00-105 LOT. 495V1068.; 352-00-105 LOT. 495Y1069.; 352-00-210 LOT. 506Y1088.; 352-00-210 LOT. 506Y1102.; 352-01-105 LOT. 297V1163.; 354-10-065 LOT. 104Y1069.; 354-10-065 LOT. 104Y1090.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female