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

Catalog Number	200-03-35
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: optetrak logic femoral component (02-010-01-0340, (b)(6)).Optetrak logic tibial tray (02-012-41-4040, (b)(6)).Optetrak logic tibial insert (02-012-05-4009, (b)(6)).H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01126, 1038671-2026-00207.The revision reported in this event was likely the result of prosthesis wear, osteolysis, failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, and insufficient bonds between the patella and the bones which led to aseptic (non-infected) patella loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, osteolysis, and loosening could not be determined as the devices were not returned for evaluation, and images 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
Report #3 of 3 for this event.It was reported a patient had bilateral total knee arthroplasties.Subsequently, the patient experienced pain and swelling in the right knee.As a result, ten (10) years, six (6) months later, the patient underwent a right knee revision procedure.A revision operative report was provided.The patient was diagnosed right knee osteolysis consistent with polymeric wear and component loosening.Intraoperatively, synovitis was observed and the patella component to be somewhat mobile.The patient was awakened and transferred to gurney and brought to recovery room in a stable condition having tolerated the procedure well.No additional information is available.

• Brand Name: ONE 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24485158
• Report Number: 1038671-2026-00208
• Device Sequence Number: 10684964
• Product Code: JWH
• UDI-Device Identifier: 10885862039668
• UDI-Public: 10885862039668
• 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: 2011
• 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): 03/02/2026

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: 06/26/2016
• Device Catalogue Number: 200-03-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2023
• Initial Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 06/29/2011
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 64 KG