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

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/18/2021

Event Type  Injury  

Event Description

Had a star ankle replacement in (b)(6) 2013.Pain had steadily increased over the last 6 months.Doctor had to perform a polyethylene insert replacement on (b)(6) 2021.Potentially broken insert.Fda safety report id #: (b)(4).

• Brand Name: STAR SCANDINAVIAN TOTAL ANKLE REPLACEMENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 12058671
• MDR Text Key: 258393656
• Report Number: MW5102110
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 77