MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, approximately two year post initial left tka, the 57 y/o female patient's poly was swapped to a 13mm poly.Patient's reason for revision was instability.There was no breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation due to hospital policy.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of instability and the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition [associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device].These devices are used for treatment not diagnosis.
Event or Problem Description
As reported, approximately two year post initial left tka, the 57 y/o female patient's poly was swapped to a 13mm poly.Patient's reason for revision was instability.There was no breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation due to hospital policy.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code, medical device problem code, component code, investigation conclusion.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 2.5,10MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15823269
• Report Number: 1038671-2022-01487
• Device Sequence Number: 6223355
• Product Code: JWH
• UDI-Device Identifier: 10885862312556
• UDI-Public: 10885862312556
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: 08/29/2026
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
• Device Catalogue Number: 02-022-51-2510
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED PATELLA 32MM 3 PEG IMPLAN.; HOLDING PIN MINI SHARP POINT 4 PK.; TRULIANT CR CEM FEM CR CEM LEFT SZ 2.5.; TRULIANT TIB FIT TRAY CEM SZ 2.5F / 1.5T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 88 KG