MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 6, 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-6012
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 2 months after a right total knee replacement, a patient underwent a revision procedure to address polyethylene wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
(b)(6) 02-022-45-6060 - truliant tib fit tray cem sz 6f / 6t.(b)(6) 02-020-11-0360 - truliant ps cem fem ps cem right sz 6.(b)(6) 200-02-38 - three peg patella 38mm.G4: corrected.H6: corrected the following: type of investigation.Manufacturer narrative updated: the reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.However, the reported prosthesis wear/failure could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 6, 12MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19439781
• Report Number: 1038671-2024-01660
• Device Sequence Number: 15523395
• Product Code: JWH
• UDI-Device Identifier: 10885862305572
• UDI-Public: 10885862305572
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 02-022-44-6012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown