MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY ANKLE REPLACEMENT LOT YT3 FL1000; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number AGILITY P.M

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

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Date 06/10/2004

Event Type  Injury  

Event Description

Had a depuy ankle replacement.After about two years, started walking on the side of my foot.Been in pain ever since the operation.Gives out and i fall down.Went back to (b)(6) they said the bone was wore and the replaced ankle was bad.Seems like the foot is not in line.Had all kinds of shoe supports made at the (b)(6), do not help.Just wondering if there was a recall on these ankles? lot number "yt3fl1000 agility p.M." thank you.Fda safety report id# (b)(4).

• Brand Name: DEPUY ANKLE REPLACEMENT LOT YT3 FL1000
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 14195239
• MDR Text Key: 290108725
• Report Number: MW5109329
• Device Sequence Number: 1
• Product Code: HSN
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: AGILITY P.M
• Device Lot Number: YT3FL1000
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ACETAN 5 MG HEART MEDS ; HYDROCOD; LEG BRACE; MEDS FOR DIABETES
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White