MAUDE Adverse Event Report: EXACTECH, INC. FEMORAL COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number FEMORAL COMPONENTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 12/01/2021

Event Type  Injury  

Event Description

As reported, a (b)(6) male patient underwent index arthroplasty (b)(6) 2018.Poly manufactured in oct 2010.Patient presented with persistent effusions and osteolysis under femoral flange.Patient underwent revision several months ago.X-rays available for evaluation.No additional information available.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

The revision reported may have been the result of wear of the polyethylene tibial insert, leading to osteolysis.The effusions reported may have been the result of infection.Additionally, a contributing factor to the osteolysis may have been the result of the insert being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed because the devices were not returned to exactech for evaluation.

• Brand Name: FEMORAL COMPONENTS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13122723
• MDR Text Key: 287677750
• Report Number: 1038671-2021-00743
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

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 Operator: Health Professional
• Device Model Number: FEMORAL COMPONENTS
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male