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 Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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
It was reported that this patient's right knee was revised approximately 12 years post initial operation.The surgeon performed a synovectomy surrounding the affected knee, there was mild osteolysis present.The patella exhibited mild wear along lateral tracking path and had disassociated from pegs.The tibial insert had mild ware medially and laterally but the femoral and tibial component were well fixed.Overall, the liner and patella were exchanged.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 corrected information.The following sections were updated: h6.The following sections were corrected: h6, h11.No device was returned for evaluation; the reported event was confirmed by review of photographs of the device.The review identified wear damage on the articular surface including pitting, delamination, and third body wear.The tibial insert damage may have been due to high contact stress between the femoral component and the tibial insert.The damage on the medial side appears to be across the entire articular surface, while the damage on the lateral side appears more posterior.This could indicate relative rotation between the femoral and tibial components through the patient's range of motion.The wear on the patella component appears to be along the lateral tracking path.It was noted that there were regions of discoloration.This appears consistent with subsurface damage and/or being stained from joint fluid.In addition, it was reported that the patella component had disassociated from the pegs.It is unclear if the disassociation occurred during the removal process, or while it was implanted, as pictures of the posterior aspect of the patella were not provided.Therefore, the fracture of the patella component is unable to be confirmed.The provided radiographs show signs of osteolysis near the distal portion of the femoral component.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, was likely the result of from tibial insert and patella component prosthesis wear.Possible causes of the observed polyethylene wear include third body wear, patient-related factors, being implanted for over 10 years, orientation of the components, inclusion of the polyethylene in the packaging recall and/or any combination of these possibilities.Fracture of the patella component could not be confirmed based on the information provided.

• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22795197
• Report Number: 1038671-2025-02743
• Device Sequence Number: 12889588
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• 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: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 11/06/2017
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female