MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. STAR ANKLE REPLACEMENT (SCANDINAVIAN TOTAL ANKLE REPLACEMENT); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/22/2023

Event Type  malfunction  

Event Description

I started having pain when walking and saw and medical professional, who sent me to have x-rays.The x-ray report stated particle disease.The orthopedic doctor ordered a cat(computed axial tomography) scan.I will have to have a replacement surgery.The particle disease is directly from the star ankle replacement.The palmore plastic is breaking off.I will be having a cat scan with contrast to see what type of damage there really is on (b)(6) 2024.

• Brand Name: STAR ANKLE REPLACEMENT (SCANDINAVIAN TOTAL ANKLE REPLACEMENT)
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL, L.P.
• MDR Report Key: 18494651
• MDR Text Key: 332910933
• Report Number: MW5150146
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALPHA LOPIC ACID.; CALCIUM.; D-3.; MAGNESIUM.; MULTI-VITAMIN.; REPINIROLE.; THYROID.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White