MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR VVC KNEETM TIBIAL INSERT, SIZE 8, 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	346-12-708
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to scar removal, insert exchange from 8 12mm vvc to 8 16mm vvc.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2021-00668; 346-14-705, s800 - revision surgery, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR VVC KNEETM TIBIAL INSERT, SIZE 8, 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19130892
• Report Number: 1644408-2024-00516
• Device Sequence Number: 4658014
• Product Code: JWH
• UDI-Device Identifier: 00190446269878
• UDI-Public: 00190446269878
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 04/17/2024

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: 06/21/2024
• Device Catalogue Number: 346-12-708
• Device Lot Number: 113T1105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male