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 Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6), 02-010-01-0240 - lgc femoral ps cem left sz 4, (b)(6), 02-012-43-4040 - lgc tibia rbktray cem sz 4f/ 4t.
Event or Problem Description
As reported, approximately 6 years and 4 months post the initial left total knee arthroplasty, the surgeon performed a synovectomy surrounding the affected knee.Mild osteolysis was present.The patella exhibited mild wear along the lateral tracking path.The tibial insert had mild wear medially and posterior to the post.The femoral and tibial components were well fixed.The tibial and femoral components were retained, while the patella and tibial insert components were replaced.The patient was revised to exactech devices.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11 the following sections were corrected: b5, h6 operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined; however, may have resulted from malalignment between implants, high contact stresses during knee flexion, patient-related conditions, inclusion of the polyethylene insert in the packaging recall, or any combination of these possibilities.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 6 years and 4 months post the initial left total knee arthroplasty, the surgeon performed a synovectomy surrounding the affected knee.Mild osteolysis was present.The patella exhibited mild wear along the lateral tracking path.The tibial insert had minimal wear.The femoral and tibial components were well fixed.The tibial and femoral components were retained, while the patella and tibial insert components were replaced.The patient was revised to exactech devices.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22312459
• Report Number: 1038671-2025-02356
• Device Sequence Number: 8812106
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 09/24/2023
• Device Catalogue Number: 200-02-35
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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
• Patient Age: 84 YR
• Patient Sex: Male