MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Limb Fracture (4518)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 13 years and 7 months post the initial right total knee arthroplasty, the patient underwent a liner and patella exchange.The patient's main complaint was discomfort and pain around the patella.Exchange of the tibial liner was more due to the surgeon already being in there.There was no sign of osteolysis.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
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), 02-010-01-0320 - logic femoral ps cem right sz 2, (b)(6), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.
Additional Manufacturer Narrative
The revision reported may have been due the reported discomfort and pain.The reason for the pain could not be conclusively determined but may be related to the periprosthetic fracture and the observed patella wear that occurred from over 13 years of use.The reason for the fracture could not be determined, but it may have been from an unreported trauma or patient-related condition.However, these cannot be confirmed since the device was not available for evaluation.

• Brand Name: THREE PEG PATELLA 29MM
• 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: 21643120
• Report Number: 1038671-2025-01617
• Device Sequence Number: 20724041
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 05/28/2012
• Device Catalogue Number: 200-02-29
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 05/30/2007
• 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: 66 YR
• Patient Sex: Female