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

Catalog Number	02-022-44-3511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: a864076, 02-012-60-1425 - tru stem ext 14mm x 25mm; a964001, 02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5; a792813, 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t; a983887, 02-029-90-4300 - sterile packed short headed pin; a567203, 200-07-35 - advanced patella 35mm 3 peg implant; a504267, 204-70-00 - tibial stem ext.Screw; s381600, 521-78-23 - threaded pin size 2.3 collared 2pk; s532757, 521-78-23 - threaded pin size 2.3 collared 2pk; s526331, 521-78-32 - threaded pin size 3.0 collarless 2pk; s528303, 521-78-36 - threaded pin size 5.1 collarless 2pk; 12000323022, a10012 - gps implant kit v2.
Event or Problem Description
It was reported that approximately 2 months after a left total knee replacement procedure, the patient underwent a revision procedure to address a quad rupture and also an incidental poly exchange.There was no reported breakage of a device or surgical delay/prolongation.No further issues or complications were reported.The patient was last known to be in stable condition following the event.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b2, d8, h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the tendon damage reported cannot be conclusively determined but may be related to patient-related conditions, surgical technique, and/or component design.However, this cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PSC 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19727197
• Report Number: 1038671-2024-02369
• Device Sequence Number: 12798852
• Product Code: JWH
• UDI-Device Identifier: 10885862305190
• UDI-Public: 10885862305190
• 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 Implanted Year: 2024
• 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): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-44-3511
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 01/10/2023
• 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; Hospitalization
• Patient Sex: Unknown