MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 6 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-6013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377); Joint effusion (4849)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-012-45-6050 - lgc tibial fit tray cem sz 6f / 5t.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 02-022-35-6013 - truliant tib imp ps insert sz 6 13mm.(b)(6), 02-022-35-6013 - truliant tib imp ps insert sz 6 13mm.Multiple mdr reports were filed for this event, please see associated report: 1038671-2021-00063.The revision reported in this event may have been due to prosthesis wear, and/or the result of an insufficient bond between the femoral component and the bone, which resulted in aseptic femoral loosening.An additional reason for the reported revision may have been inclusion of the polyethylene in the packaging recall z-0023-2022.Prosthesis wear was confirmed on the tibial insert; however, the reported femoral loosening and patellar prosthesis wear could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported approximately 27 months after a bilateral knee revision procedure; a patient underwent a second left total knee revision procedure.The patient experienced prosthesis wear, joint effusion and cysts.A revision operative report was provided.Post operative diagnosis noted aseptic femoral loosening and femoral osteolysis.The patient was revised to a competitor's construct.No medical or surgical interventions were reported.The patient was last known to be in stable condition following the event.No additional information is available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 6 13MM
• 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
• MDR Report Key: 22467333
• Report Number: 1038671-2025-02464
• Device Sequence Number: 18139082
• Product Code: JWH
• UDI-Device Identifier: 10885862304742
• UDI-Public: 10885862304742
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 02-022-35-6013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male