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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Joint Laxity (4526)

Event Date 03/20/2024

Event Type  Injury  

Event Description

Revision surgery - due to scar removal, insert exchange from 8 12mm vvc to 8 16mm vvc.

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
• Type of Device: 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
• MDR Text Key: 340446816
• Report Number: 1644408-2024-00516
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00190446269878
• UDI-Public: 00190446269878
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 346-12-708
• Device Lot Number: 113T1105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male