MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-4513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had left knee replacement on (b)(6)2018.They underwent left knee revision on (b)(6)2023, approximately 4 years 2 months after their initial implantation.Postoperative diagnosis: failed left total knee polyethylene due to premature wear and poly recall, as well as osteolysis of the left femoral component.There were well-fixed tibial and patellar components.There was a loose femoral component that was loose from the cement mantle.There was moderate polyethylene wear visible and palpable within the tibial polyethylene.There was also found to be polyethylene debris encapsulated within the synovium.The cement mantle was found to remain on the femur and there was no cement adherent to the back side of the femoral component.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 5506478 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t.5577325 204-70-00 - tibial stem ext.Screw.5584693 02-012-60-1425 - tru stem ext 14mm x 25mm.5623365 02-020-11-0245 - truliant ps cem fem ps cem left sz 4.5.5675611 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 17139908
• Report Number: 1038671-2023-01368
• Device Sequence Number: 20279138
• Product Code: JWH
• UDI-Device Identifier: 10885862304568
• UDI-Public: 10885862304568
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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
• Device Expiration Date: 04/18/2025
• Device Model Number: 02-022-35-4513
• Device Catalogue Number: 02-022-35-4513
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male