MAUDE Adverse Event Report: ENCORE MEDICAL L.P INSERT, STD., PRIMARY, SIZE2 11MM CM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 385-11-502

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 02/27/2024

Event Type  Injury  

Event Description

Revision surgery - due to instability.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: INSERT, STD., PRIMARY, SIZE2 11MM CM
• 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: 18991889
• MDR Text Key: 338885071
• Report Number: 1644408-2024-00349
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888912117821
• UDI-Public: 00888912117821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000590
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 385-11-502
• Device Lot Number: 53971930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 120-01-029 LOT: 468A1037; 202-01-104 LOT: 731A1094; 324-01-102 LOT: 229B1083
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female