MAUDE Adverse Event Report: DJO GLOBAL/ENCORE MEDICAL, L.P. STAR DEVICE ANKLE REPLACEMENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 02/25/2020

Event Type  Injury  

Event Description

At my 12 month follow up with dr.(b)(6) at (b)(6) in (b)(6), the x-ray showed that the star device ankle replacement had failed.Dr (b)(6) solution was for me to wear an ankle brace for the rest of my life and take miloxicam for the pain i was experiencing.I was dissatisfied with both recommendations.Fda safety report id # (b)(4).

• Brand Name: STAR DEVICE ANKLE REPLACEMENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): DJO GLOBAL/ENCORE MEDICAL, L.P.
• MDR Report Key: 14171129
• MDR Text Key: 289902554
• Report Number: MW5109247
• Device Sequence Number: 1
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White