MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ DEPUY ACETABULAR CUP; HIP REPLACEMENT

Model Number 62 MM

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Pain (1994); Loss of Range of Motion (2032); Renal Failure (2041); Swelling (2091); Toxicity (2333)

Event Date 03/01/2007

Event Type  Injury  

Event Description

I had a hip replacement in (b)(6) 2006.Soon after surgery, i developed limited movement issues and different pain in that area.Over time now, i have developed a number of issues of the johnson and johnson depuy hip parts.The parts are cobalt and chromium.I have kidney failure and cobalt and chromium poisoning.I have had a heart attack and numerous tumors near my hip replacement.I have been to other hip surgeons who won't touch it for replacement.They say if it isn't recalled they won't fix it.I really want to report to you the issues for a possible future recall.I have all lot numbers of what was put into my body.

• Brand Name: ACETABULAR CUP
• Type of Device: HIP REPLACEMENT
• Manufacturer (Section D): JOHNSON AND JOHNSON/ DEPUY
• MDR Report Key: 7137410
• MDR Text Key: 95528565
• Report Number: MW5074127
• Device Sequence Number: 1
• Product Code: KWA
• 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: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 62 MM
• Device Catalogue Number: 1217-22-062
• Device Lot Number: Z3XDM1000
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA.; RX MEDS: LIST CAN BE SENT TO YOU.
• Patient Outcome(s): Disability
• Patient Weight: 104