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

Model Number STAR-PE-2

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 04/13/2021

Event Type  Injury  

Event Description

History: i received a star total ankle replacement (stryker) by (b)(6) 2014.During a subsequent surgery for a ruptured peroneal tendon in (b)(6) 2015, my surgeon, (b)(6), also replaced the pe mobile bearing.Adverse event: at 8 pm mst on (b)(6) 2021, i experienced spontaneous, debilitating, mesial pain in my (r) ankle.I could not bear weight without excruciating pain.Upon waking the following morning, the symptoms persisted.Suspecting pe fracture, i went to the (b)(6) and obtained x-ray and ct imaging.Imaging did not reveal the source of pain.Currently, i am waiting to be scheduled for an appointment with (b)(6) for evaluation and treatment.Fda safety report id# (b)(4).

• Brand Name: SCANDINAVIAN TOTAL ANKLE REPLACEMENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 11692984
• MDR Text Key: 246467890
• Report Number: MW5100847
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STAR-PE-2
• 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): Disability
• Patient Age: 55 YR
• Patient Weight: 79