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

Model Number 400-263

Device Problem Degraded (1153)

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

Event Date 03/01/2022

Event Type  Injury  

Event Description

Problems with stryker star ankle replacement.The prosthesis was implanted in (b)(6) 2017.I began having significant pain issues in (b)(6) 2022.A cat scan done in (b)(6) 2022 showed a deterioration of the implant similar to what is described in the fda report issued march 15 2021.Additional surgery will be required to either repair or replace the device.My doctor is alan davis at the cleveland clinic in avon oh.All tests were also done at the cleveland clinic.Contact info for the doctor is (b)(6).Tel: (b)(6).Fda safety report id# (b)(4).

• Brand Name: STRYKER STAR ANKLE REPLACEMENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 15163415
• MDR Text Key: 297321970
• Report Number: MW5111254
• Device Sequence Number: 2
• Product Code: NTG
• Combination Product (y/n): N
• 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: 08/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 400-263
• Device Lot Number: 1446086
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; CYMBALTA; LEVOTHYROXINE ; PLAQUENIL ; VITAMIN D3
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White