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	Synovitis (2094); Osteolysis (2377)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-01-0340 - lgc femoral ps cem right sz 4: (b)(6).02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t: (b)(6).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.
Event or Problem Description
As reported, approximately 8 years post the initial right total knee arthroplasty, the surgeon performed a synovectomy surrounding the affected knee.Mild osteolysis was present.The patella exhibited severe wear along the lateral tracking path.The tibial insert had severe wear on the medial and lateral articular surface, and posterior of post.The femoral and tibial components were well fixed.The tibial and femoral components were retained while the patella and tibial insert were replaced.There was no reported 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: h6.No device was returned for evaluation; the reported event was confirmed by review of radiograph images provided.The review identified that in the pre-revision radiographs the point of articulation between the tibial insert and the femoral component appears to be shifted posteriorly.Additionally, the trajectory of the base of the tibial tray appears to be malaligned with the medial aspect positioned more superiorly than the lateral aspect.The pre-revision radiograph appears unremarkable in all other regards.An image was provided of the polyethylene components.Both components appear to be worn.Patellar wear most often occurs secondary to lateral tracking of the patella and contact with the trochlear ridge of the femoral component.Patellar maltracking following knee arthroplasty may occur secondary to a number of factors including pre-existing patellar maltracking, implant positioning, patellar thickness, obesity, and/or a tight lateral retinaculum.There appears to be localized damage near the edge of the patella.The rim damage may be the result of tool damage during removal of the component during the revision surgery.The articular surface of the tibial insert appears to have undergone fatigue wear with subsurface propagation of shear cracking prior to the eventual surface layer delamination and third body wear (pitting).Fatigue wear, and particularly delamination, occurs secondary to cyclic shear stress between the tibial and femoral components.Third body wear occurs when a third body, such as a fragment of bone or bone cement, gets trapped between the articulating surfaces of the tibial insert and femoral component.As the patient moves, the third body creates scratches, and sometimes pitting, on the surface of the polyethylene component.There appears to be wear on the posterior aspect of the tibial spine and subsurface damage on the superior aspect of the spine.Posterior wear of the tibial insert spine is likely to occur when the post is chronically subjected to higher-than-normal shear forces and/or rapid, rather than gradual engagement of the femoral cam with the tibial insert spine during knee flexion.There appears to be polyethylene deformation, which appears to be cold flow, possibly as a result of high in vivo loading over 8 years of implanted use.Lastly, the overall wear pattern appears to be shifted posteriorly.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, may have resulted from prosthesis wear.The cause of the polyethylene wear cannot be conclusively determined; however, the patellar wear may be secondary to lateral tracking of the patella against the femoral component and the insert wear may be secondary to high in vivo loading, posterior articulation of the femoral component, and contact between the femoral cam and the posterior aspect of the tibial spine.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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23632153
• Report Number: 1038671-2025-03428
• Device Sequence Number: 16030791
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• 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: 2017
• 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): 01/29/2026

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: 12/21/2021
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male