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
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to instability.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See d4 expiration date, d10, h4 and h11.Complaint has been evaluated and is similar to previous report number 1644408-2018-00855; 385-11-502, s814 - stability, poor joint, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.Note: the revision dt/invoice was not provided or found, after a search of djo records.

• Brand Name: INSERT, STD., PRIMARY, SIZE2 11MM CM
• 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: 18991889
• Report Number: 1644408-2024-00349
• Device Sequence Number: 20730503
• Product Code: JWH
• UDI-Device Identifier: 00888912117821
• UDI-Public: 00888912117821
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2024

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: 11/30/2013
• Device Catalogue Number: 385-11-502
• Device Lot Number: 53971930
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2010
• 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: 120-01-029 LOT: 468A1037; 202-01-104 LOT: 731A1094; 324-01-102 LOT: 229B1083
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female