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

Catalog Number	02-022-47-4010
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 6579681 02-020-13-0340 - truliant cr cem fem cr cem right sz 4 6705376 02-022-45-4050 - truliant tib fit tray cem sz 4f / 5t 6907763 201-78-15 - holding pin mini sharp point 4 pk 6919787 200-07-32 - advanced patella 32mm 3 peg implant s244989 521-78-23 - threaded pin size 2.3 collared 2pk s288503 521-78-32 - threaded pin size 3.0 collarless 2pk h7: z-0023-2022.
Event or Problem Description
As reported, the patient has a history of 2 synovectomies through knee scope.The patient had an initial right tka on (b)(6) 2021.The patient presented with signs of infection.The patient had a poly exchange on (b)(6) 2023 and i&d was performed.Poly wear was visual on medial compartment with pitting.No issues with surgery.No other patient information/medical history reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear and the reported infection.Potential contributing factors of user and patient related conditions regarding the signs of infection and the prosthesis wear could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear and the reported infection.Potential contributing factors of user and patient related conditions regarding the signs of infection and the prosthesis wear could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CR STD, SIZE 4, 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17902037
• Report Number: 1038671-2023-02480
• Device Sequence Number: 7561281
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 03/12/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown