MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 103 months after a right total knee replacement procedure, the patient underwent a revision procedure to address right knee pain and a large lateral osteophyte on patella.Revision surgery operative notes were provided.Preoperative and postoperative diagnoses indicated right knee pain following total knee arthroplasty.The surgeon noted that most of her symptoms were likely related to the large patellar osteophyte and lateral tilt, although her polyethylene was subject to recall.Findings indicated her metallic components appeared to be well fixed.She had no appreciable wear on the polyethylene insert, and it was replaced with the same thickness crc insert.The large lateral osteophyte was removed with electrocautery and a micro-oscillating saw.The surgeon performed a slight lateral release to improve her tilt.The patient was awakened and taken to recovery in satisfactory condition.There were no immediate complications.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-012-35-2011 - logic tibia ps mod insrt sz 2 11mm.(b)(6) - 02-010-01-0320 - logic femoral ps cem right sz 2.(b)(6) - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6) - 200-02-32 - three peg patella 32mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03828.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of patellar osteophyte 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.D1: corrected.D4: corrected.G4: corrected.H6: corrected investigation clinical codes.

• Brand Name: THREE PEG PATELLA 32MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22211623
• Report Number: 1038671-2025-02300
• Device Sequence Number: 8749224
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2020
• Device Catalogue Number: 200-02-32
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female