MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR STD, SIZE 4, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-47-4010
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post op the initial right tka, this male patient was revised due to premature polyethylene wear of the tibial insert.Following the revision surgery, plaintiff continues to be limited in his activities of daily living.Despite undergoing revision surgery, plaintiff experiences daily pain and discomfort in his right knee which limits his activities of daily living and impacts his quality of life.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Product information has been identified, the following fields have been updated: d1, d4, g4, h4, h7, and h9.H6: investigation results - the revision reported was likely the result of prosthesis wear as stated in the legal documentation.However, the root cause of the prosthesis cannot be determined as the device was not available for evaluation and images, pre-revision radiographs, and operative notes were not provided.Information has been added to the following fields: d8, e3, and e4.

• Brand Name: TRULIANT TIB IMP CR STD, SIZE 4, 10MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15713601
• Report Number: 1038671-2022-01392
• Device Sequence Number: 15108207
• Product Code: JWH
• UDI-Device Identifier: 10885862311382
• UDI-Public: 10885862311382
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 09/05/2025
• Device Catalogue Number: 02-022-47-4010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male