MAUDE Adverse Event Report: STRYKER GMBH STAR ANKLE JOINT IMPLANT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 12/04/2020

Event Type  Injury  

Event Description

I had a total ankle joint replacement surgery done on my left ankle due to rheumatoid arthritis on (b)(6) 2020.I have had nothing but issues and will have to have a revision done in the next month as the implant is too large for my ankle and causes ongoing pain and swelling.I know there have been issues with the star implant so wanted to report this.Fda safety report id # (b)(4).

• Brand Name: STAR ANKLE JOINT IMPLANT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 12438845
• MDR Text Key: 270800950
• Report Number: MW5103767
• Device Sequence Number: 1
• Product Code: NTG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 64