MAUDE Adverse Event Report: METAL ON METAL HIP IMPLANT; PROSTHESIS HIP

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Death (1802); Sepsis (2067); Ambulation Difficulties (2544); Multiple Organ Failure (3261)

Event Date 09/11/2001

Event Type  Death  

Event Description

The details of this incident is so extensive and i have no computer that it would take years for me to write it all.I'd much rather speak to an individual.There was a list so long on his death certificate due to the implant.The hosp visits could fill a binder in itself.My father was healthy until this implant which still right afterward he couldn't walk right.Reporter stated, on (b)(6) 2019, that her father had a hip surgery at one of 5 worst hospitals in (b)(6).She went on to state that her father's hip implant was protruding from the skin and he developed sepsis, and multiple organ failure, and subsequently passed away.Doctors wouldn't release anything to me.Fda safety report id# (b)(6).

• Brand Name: METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS HIP
• MDR Report Key: 8915428
• MDR Text Key: 155184197
• Report Number: MW5089205
• Device Sequence Number: 1
• Product Code: JDI
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 41 YR