MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-2009
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 02-020-11-0220 - truliant ps cem fem ps cem left sz 2, 5542756.02-022-45-2020 - truliant tib fit tray cem sz 2f/2t, 6478723.200-02-32 - three peg patella 32mm, 6502571.201-78-15 - holding pin mini sharp point 4 pk, 6578989.201-78-89 - 3" drill bit, mod.Hex 2 pack, 6122242.203-96-67 - fan sawblade ez2213f.M63 90x22 1.27mm strkr 5/6/7, 250522.521-78-23 - threaded pin size 2.3 collared 2pk, s045200.521-78-31 - threaded pin size 2.6 collarless 2pk, s074582.
Event or Problem Description
As reported, approximately 3 years and 10 months post the initial left tka, the patient was revised due to instability.The poly was swapped out and seemed normal.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
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.The reason for the reported revision due to instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Subluxation and dislocation are known risks, as outlined in the ifu.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 PSC INSERT SZ 2, 9MM
• 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: 20248058
• Report Number: 1038671-2024-03592
• Device Sequence Number: 20641872
• Product Code: JWH
• UDI-Device Identifier: 10885862304896
• UDI-Public: 10885862304896
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-44-2009
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 08/13/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female