MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-022-44-4010
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, this patient had a tka on (b)(6) 2019 performed by dr.(b)(6).The patient presented with pain and synovitis and was revised on (b)(6) 2022 and a new insert was placed.Only mild wear was noted.The patient had good rom and was last known to be in stable condition.
Additional Manufacturer Narrative
H3: the reason for the pain and synovitis leading to the revision reported cannot be determined from the information provided but does not appear to be related to prosthesis wear as the provided images appear unremarkable.However, this cannot be confirmed as the devices were not returned for evaluation.A contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.D10: 02-020-11-0340 - truliant ps cem fem ps cem right sz 4 5972889.02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t 6151122.200-02-35 - three peg patella 35mm 6161992.201-78-15 - holding pin mini sharp point 4 pk 5967752.Correctional/removal number: z-0023-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6 clinical code, impact code, problem code and component code.
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.The reason for the pain and synovitis leading to the revision reported cannot be determined from the information provided but does not appear to be related to prosthesis wear as the provided images appear unremarkable.However, this cannot be confirmed as the devices were not returned for evaluation.A contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.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 4, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15121694
• Report Number: 1038671-2022-00854
• Device Sequence Number: 5647017
• Product Code: JWH
• UDI-Device Identifier: 10885862305275
• UDI-Public: 10885862305275
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2025

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 Model Number: 02-022-44-4010
• Device Catalogue Number: 02-022-44-4010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 12/31/2024; 08/28/2025
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 02/02/2023; 01/02/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown