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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/18/2021

Event Type  Injury  

Event Description

I had a total ankle replacement with the star device (b)(6) 2021.In (b)(6), my podiatrist who was trimming my nails, notice that my foot was beginning to turn outward.Myself and my family noticed i was walking again on the outside of my foot.I informed the podiatrist who did the surgery, dr.(b)(6), that i would like to get an x-ray to see if my foot had turned.On (b)(6) 2021, the x-ray confirmed that a part of the device was separating, which was causing my ankle to turn.The surgeon suggested that another surgery was needed to prop up the device in order to prevent further turning of the ankle.Fda safety report id# (b)(4).

• Brand Name: STAR
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 12961050
• MDR Text Key: 282040944
• Report Number: MW5105916
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White