MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-38
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 124 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.Revision surgery operative notes were provided.Findings indicated wear of the patella and tibial polyethylene insert, a loose tibial component, and tibial bone loss.The surgeon performed a revision right total knee arthroplasty using a competitor¿s devices.Patient was awakened, extubated, and brought to the recovery room in stable condition.He tolerated the procedure well and there were no know complications.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-01-0350 - logic femoral ps cem right sz 5.(b)(6) - 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm.(b)(6) - 02-012-41-5040 - logic tibia traptray cem sz 5f/4t.(b)(6) - 204-32-01 - fluted stem extension 11l x 12 mm.(b)(6) - 204-70-00 - tibial stem ext.Screw.(b)(6) - 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) - 201-78-81 - 3" trocar, mod.Hex 2pk.(b)(6) - 201-78-81 - 3" trocar, mod.Hex 2pk.(b)(6) - 203-90-03 - 11-3978 stablecut gts osc system 6105x19x1.27.(b)(6) - 203-96-41 - (11-3974) stryker sys 6 90x13x1.27.(b)(6) - 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02581, 1038671-2025-02650.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
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: THREE PEG PATELLA 38MM
• 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: 22681775
• Report Number: 1038671-2025-02651
• Device Sequence Number: 21223920
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 09/10/2025

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: 02/04/2017
• Device Catalogue Number: 200-02-38
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• 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: 73 YR
• Patient Sex: Male