MAUDE Adverse Event Report: JOHNSON AND JOHNSON HIP REPLACEMENT SYSTEM; HIPT REPLACEMENT SYSTEM

Lot Number SEE SCANNED PAGE.

Device Problems Failure to Align (2522); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Date 10/27/2016

Event Type  Injury  

Event Description

Had my left hip replaced after it was done my left food was inverted in ward had to have a femur osteometry to fix foot.Had left hip replaced, then my left foot was turned inward so i had to have a femur ostometry to fix the foot.It's 9 months now still having pain in the hip and leg and the hip makes clicking noise.Morphine for the pain, dilaudid.B complex, probiotic.

• Brand Name: HIP REPLACEMENT SYSTEM
• Type of Device: HIPT REPLACEMENT SYSTEM
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 6683976
• MDR Text Key: 79050327
• Report Number: MW5070764
• Device Sequence Number: 1
• Product Code: LZO
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: SEE SCANNED PAGE.
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Disability
• Patient Age: 41 YR
• Patient Weight: 40