MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-4011
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: a10012 - gps implant kit v2 (b)(6).02-020-13-0240 - truliant cr cem fem cr cem left sz 4 (b)(6).201-78-15 - holding pin mini sharp point 4 pk (b)(6).02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t (b)(6).521-78-32 - threaded pin size 3.0 collarless 2pk (b)(6).521-78-32 - threaded pin size 3.0 collarless 2pk (b)(6).521-78-23 - threaded pin size 2.3 collared 2pk (b)(6).
Event or Problem Description
As reported, the patient was revised due to pain.The patella was removed and replaced with a competitor's patella.A new 12mm crc vit e insert was also placed.No further information provided.
Additional Manufacturer Narrative
The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the device was not available for evaluation, relevant patient information, or radiographs were not provided.An image of the tibial insert was provided but it appears unremarkable for an explanted component.An additional contributing factor to the revision may have been inclusion of the polyethylene in the packaging recall.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20821751
• Report Number: 1038671-2024-04562
• Device Sequence Number: 7813659
• Product Code: JWH
• UDI-Device Identifier: 10885862307767
• UDI-Public: 10885862307767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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 Catalogue Number: 02-022-51-4011
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 07/08/2019
• 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: Hospitalization
• Patient Sex: Unknown