MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT POR TIB TRAY SIZE 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-55-3030
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2022-01175 d10: concomitants: 02-022-35-3009, (b)(6) - truliant tib imp ps insert sz 3 9mm, 02-020-12-0330, (b)(6) - truliant ps por fem ps por right sz 3 200-02-35, (b)(6) - three peg patella 35mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and femoral loosening.The reported prosthesis wear, tibial loosening, and femoral loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Additionally, this device was packaged after initiation of the recall and was not packaged in a non-conforming vacuum bag.
Event or Problem Description
As reported, approximately 1.5 years post op the initial right tka, this 52 y/o male patient was revised due to pain.Patient came in with painful knee ".Clean to do to liner recall".Surgeon revised a porous knee to a competitor's knee replacement system.Patient outcome is unknown, representative was not allowed to be present for the surgery.Devices are not returning; implants were given to a lawyer.No additional information.

• Brand Name: TRULIANT POR TIB TRAY SIZE 3F/3T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20526405
• Report Number: 1038671-2024-04113
• Device Sequence Number: 15745941
• Product Code: JWH
• UDI-Device Identifier: 10885862317131
• UDI-Public: 10885862317131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-55-3030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/24/2024
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male