MAUDE Adverse Event Report: EXACTECH, INC. INSET PATELLA 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-05-26
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.As reported, this patient had initial bilateral total knee arthroplasties, subsequently, ten (10) years, eight (8) months later, the patient experienced left knee pain, stiffness, and swelling.As a result, the patient underwent a revision of the left knee due to prosthesis wear and osteolysis.It was noted the patella component was worn and the tibial polyethylene component showed significant pitting, delamination and discoloration that required irrigation of the knee joint.Additionally, it was noted the femoral and tibial components showed to be well fixed.The patient left the operating room in stable condition.Explants were returned for evaluation as well as images and radiographs.No additional information is available.
Additional Manufacturer Narrative
D10: 200-01-03 - cemented cr femoral sz 3 (b)(6).200-04-34 - cemented finned tib.Tra sz 3f/4t (b)(6).200-23-15 - cr tibial insert sz3, 15mm (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01333.The complaint devices were evaluated, and the reported event was confirmed.The evaluation identified fatigue wear with pitting/third body wear and delamination secondary to cyclic shear stress between the tibial and femoral components.The wear pattern of the tibial insert suggests that the femoral component was externally rotated with respect to the tibial tray.However, the relative alignment of the components in the transverse plane cannot be confirmed due to the orientation of the lower limb in the provided radiograph.The patella component appears worn on the articular surface, consistent with pitting/third body wear and articulating against the patellar groove and/or ridges of the femoral component for over 10 years.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.The revision reported was likely the result of malalignment between the femoral and tibial components, instability, third body wear, patient-related conditions, or any combination of these possibilities after being implanted for over 10 years, which led to wear of the polyethylene components.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: INSET PATELLA 26MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 24664976
• Report Number: 1038671-2026-00310
• Device Sequence Number: 18463981
• Product Code: JWH
• UDI-Device Identifier: 10885862039842
• UDI-Public: 10885862039842
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 03/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2016
• Device Catalogue Number: 200-05-26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• 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; Required Intervention
• Patient Sex: Male
• Patient Weight: 107 KG