MAUDE Adverse Event Report: Exactech, Inc. ADVANCED PATELLA 32MM 3 PEG IMPLANT; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	200-07-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #3 of 3 for this event.It was reported this patient underwent bilateral total knee arthroplasties.Subsequently four (4) years, eight (8) months later, the patient experienced pain and lysis of the right knee.As a result, the patient underwent a right knee revision procedure due to polyethylene wear and lysis secondary to a recalled polyethylene insert and femoral loosening.An operative report was provided.Intraoperatively, synovitis was observed.The patella was significantly damaged, linear wear markings on the articular surface of the tibial insert and the femoral was removed cleanly with no attachment.The patient was awoken from anesthesia and transferred to the recovery room in stable condition.Additionally, it is reported via legal documentation this patient alleges experiencing significant pain and discomfort, stiffness, gait impairment, difficulty walking, difficulty ascending and descending stairs, inflammation, swelling and other injuries presently undiagnosed.

• Brand Name: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 50484727
• Report Number: 1038671-2026-01095
• Device Sequence Number: 10093469
• Product Code: JWH
• UDI-Device Identifier: 10885862314284
• UDI-Public: 10885862314284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 02/19/2023
• Device Catalogue Number: 200-07-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 02/21/2018
• 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 Sex: Male