MAUDE Adverse Event Report: Exactech, Inc. CEMENTED FINNED TIB. TRA SZ 3F/2T; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	200-04-32
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.It was reported via legal notification this patient, underwent an initial left total knee arthroplasty.Subsequently, then (10) years, three (3) months later, the patient experienced pain, swelling, instability, and bone loss of the left knee.As a result, the patient underwent a revision surgery.An operative report was provided.Post operative diagnosis noted mechanical loosening of internal left knee prosthetic joint and polyethylene wear of left knee joint prosthesis.Intraoperatively, the tibial component was noted to be loose.The patient was awoken and taken to the recovery room in stable condition.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 3F/2T
• 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: 50301361
• Report Number: 1038671-2026-01042
• Device Sequence Number: 10724178
• Product Code: JWH
• UDI-Device Identifier: 10885862039729
• UDI-Public: 10885862039729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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
• Device Expiration Date: 01/04/2015
• Device Catalogue Number: 200-04-32
• 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: 02/22/2023
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 01/06/2010
• 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
• Patient Sex: Female