MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4.5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-51-3509
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-020-13-0335, 6118379 - truliant cr cem fem cr cem right sz 3.5.02-022-45-3535, 6036478 - truliant tib fit tray cem sz 3.5f / 3.5t.200-02-38, 6067876 - three peg patella 38mm.201-78-15, 5972593 - holding pin mini sharp point 4 ok.521-78-23, s017632 - threading pin size 2.3 collared 2pk.521-78-32, s005968 - threading pin size 3.0 collarless 2pk.521-78-32, s006139 - threading pin size 3.0 collarless 2pk.521-78-36, s003456 - threading pin size 5.1 collarless 2pk.
Event or Problem Description
As reported, the patient returned to clinic with pain and tightness.This week on monday the patient was revised again due to pain and tightness.Surgeon noted non compliance with post op instructions.The insert was dropped from 15 to 12mm and rom was significantly improved.Implants not available to return.No further information available.Patient last known to be in stable condition.
Additional Manufacturer Narrative
Section h10: (h3) 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 the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and noncompliance.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4, d6a, d8, d10, g4, h4, h6 clinical code, medical device problem code, component code, investigation findings codes.(d10) concomitant device(s): 02-020-11-0245, 5382406 - truliant ps cem fem ps cem left sz 4.5.02-022-45-4535, 5024223 - truliant tib fit tray cem sz 4.5f/3.5t.200-02-35, 5200293 - three peg patella 35mm.201-78-15, 5197939 - holding pin mini sharp point 4 pk.521-78-31, 5394106 - threaded pin size 2.6 collarless 2pk.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4.5, 15MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15245404
• Report Number: 1038671-2022-00928
• Device Sequence Number: 12238644
• Product Code: JWH
• UDI-Device Identifier: 10885862305411
• UDI-Public: 10885862305411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: 02-022-51-3509
• Device Catalogue Number: 02-022-44-4515
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 01/16/2026
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/15/2022; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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 H10; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female