MAUDE Adverse Event Report: ENCORE MEDICAL L.P INSERT, STD., PRIMARY, SIZE8 11MM CM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 385-11-508

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

Patient Problems Joint Laxity (4526); Implant Pain (4561)

Event Date 09/22/2023

Event Type  Injury  

Event Description

Revision surgery - due to pain and laxity.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2019-00097; 508-44-101, s803 - dislocation, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: INSERT, STD., PRIMARY, SIZE8 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: 17962372
• MDR Text Key: 326004623
• Report Number: 1644408-2023-01451
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888912117876
• UDI-Public: 00888912117876
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 385-11-508
• Device Lot Number: 53885894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 73 YR
• Patient Sex: Male