MAUDE Adverse Event Report: JOHNSON & JOHNSON DEPUY ROTATING PLATFORM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Event Description

In (b)(6) 2010 i had a rt knee replacement, (b)(6) 2010 had to have it manipulated, (b)(6) of 2011 had revision on rt knee, in (b)(6) of 2013 second doctor realized i was allergic to nickel in the depuy knee and had to replace the whole knee again.Not going through rehab still and not off the narcotics; yet this will be a whole new problem to deal with.It took 3 years to figure out i was allergic to the cobalt / nickel.I was only (b)(6) and in good health when this all started.Have not been able to work.Life has been hell, a simple allergy test would have prevented this.

• Brand Name: DEPUY ROTATING PLATFORM
• Type of Device: DEPUY ROTATING PLATFORM
• Manufacturer (Section D): JOHNSON & JOHNSON
• MDR Report Key: 3606607
• MDR Text Key: 4070104
• Report Number: MW5034151
• Device Sequence Number: 1
• Product Code: HRZ
• 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: 01/30/2014

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?: No
• Device Operator: Other
• Other Device ID Number: ROTATING PLATFORM
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 86