MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-35
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.As reported a patient had a left total knee arthroplasty.Subsequently, seven (7) years, eight (8) months later, the patient experienced osteolysis pain and instability with recurrent effusions.As a result, the patient underwent a left knee revision procedure.A revision operative report was provided.Intraoperatively, global instability and a large effusion without gross infection was observed.Synovitis showed consistent with polyethylene wear.It was noted the femoral component was not grossly loose however debonded from the cement mantle.The tibia was well fixed.There was significant osteolysis at the tibia with uncontained defect, and bone loss of the tibia and femur.The patella component was found to be loose with undermining osteolysis.The patient was revised to another manufacturer's construct.The patient was transferred to the recovery room in stable condition.Additionally, it was reported via legal documentation the patient experienced and/or continues to experience significant pain and discomfort; gait impairment, poor balance, difficulty walking, component part loosening, soft tissue damage and bone loss.No additional information is available.

• Brand Name: THREE PEG PATELLA 35MM
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25652368
• Report Number: 1038671-2026-00806
• Device Sequence Number: 5877393
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 01/14/2020
• Device Catalogue Number: 200-02-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 01/16/2015
• 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: 68 YR
• Patient Sex: Male