MAUDE Adverse Event Report: Exactech, Inc. ADVANCED PATELLA 35MM 3 PEG IMPLANT; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	200-07-35
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, swelling and prosthesis wear.As a result, the patient underwent a left knee revision approximately 1 year and 6 months after initial implantation.During the revision it was noted that the femoral component was loose.The patient was transferred to the recovery room in stable condition.No further information available.

• Brand Name: ADVANCED PATELLA 35MM 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 66th ct; gainesville, FL 32653
• MDR Report Key: 50189477
• Report Number: 1038671-2026-00986
• Device Sequence Number: 9981412
• Product Code: JWH
• UDI-Device Identifier: 10885862314291
• UDI-Public: 10885862314291
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 04/04/2026
• Device Catalogue Number: 200-07-35
• 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: 06/18/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 04/05/2021
• 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: Female