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

Device Problem Product Quality Problem (1506)

Patient Problems Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/05/2020

Event Type  Injury  

Event Description

Ankle implant was before 2014.It has never been right, but was getting unbearable to walk on.After follow ups and many tests the implant was removed and my foot fused.The implant ruined my bones to the point of no other option but to fuse my foot.I am very upset at the muscle loss and other issues at the negligence of stryker and no one warning me of the issues with the implant.I might have been able to save my bones to put a new implant.Fda safety report id# (b)(4).

• Brand Name: STAR ANKLE IMPLANT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 12540269
• MDR Text Key: 273825970
• Report Number: MW5104236
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention