MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 5 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately two years post initial left tka, a 64 yo male patient had a revision due to the poly device recall; no other reason reported.Device was received (b)(6) 2022.No additional information available.
Additional Manufacturer Narrative
Concomitant products: truliant ps cem fem ps cem left sz 5 (cat# 02-020-11-0250 / serial# (b)(4), truliant tib fit tray cem sz 5f / 4t (cat# 02-022-45-5040 / serial# (b)(4), three peg patella 32mm (cat# 200-02-32 / serial# (b)(4), holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4), gps implant kit v2 (cat# a10012 / serial# (b)(4).As reported, approximately two years post initial left tka, a 64 yo male patient had a revision due to the poly device recall; no other reason reported.Device was received 13 dec 22.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision is reportedly due to the device poly recall; no other reason stated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2022-01628.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16092480
• Report Number: 1038671-2023-00002
• Device Sequence Number: 20494329
• Product Code: JWH
• UDI-Device Identifier: 10885862304629
• UDI-Public: 10885862304629
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 04/16/2026

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 Model Number: TRULIANT TIB IMP PS INSERT SZ 5 10MM
• Device Catalogue Number: 02-022-35-5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male