MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3511
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left knee was revised.Patient had a poly swap.Patient was last known to be in stable condition following the event.No other patient information reported.No x-rays or photos provided, unable to obtain.No product information provided.Product not returning reason not reported.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the reported revision cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, loosening, infection, fracture, instability, and/or patient related factors.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information, images, or radiographs were not provided.Serial number, expiration and manufactured dates unknown.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 CRC INSERT SZ 3.5, 11MM
• 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: 17118633
• Report Number: 1038671-2023-01329
• Device Sequence Number: 17785619
• Product Code: JWH
• UDI-Device Identifier: 10885862307705
• UDI-Public: 10885862307705
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Catalogue Number: 02-022-51-3511
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown