MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 41MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-41
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-01-0360 - lgc femoral ps cem right sz 6; 02-012-44-6013 - logic tibia implant psc insert, sz 6, 13mm; 02-012-45-6060 - lgc tibial fit tray cem sz 6f / 6t; 204-34-02 - fluted stem extension 25l x 14 mm; 204-70-00 - tibial stem ext.Screw.The revision reported was likely the result of the patient¿s reported fall which led to pain.The reported prosthesis wear may have been the result of the orientation of the components, instability, patient related factors, or any combination of these possibilities.However, this cannot be confirmed because the components were not returned for evaluation.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years.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
As reported, approximately 3.5 years post op initial right tka, this 72 y/o male patient was revised.Patient presented with a sore knee after a fall from a ladder.After opened the knee, surgeon found poly and osteolysis issue.This seems to be from the patella wear.Liner and patella were exchanged.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos & x-rays attached.Product not returning - it was discarded.

• Brand Name: THREE PEG PATELLA 41MM
• 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: 21606629
• Report Number: 1038671-2025-01568
• Device Sequence Number: 8896049
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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 Expiration Date: 09/08/2019
• Device Catalogue Number: 200-02-41
• 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: 08/15/2023
• Initial Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 09/10/2014
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 100 KG