FDA Adverse Event Injury Summary report: N

DEPUY INC

MDR report key: 2597368 · Received May 24, 2012

Report

Report Number
MW5025584
Event Type
Injury
Date Received
May 24, 2012
Date of Event
May 23, 2007
Report Date
May 24, 2012
Manufacturer
DEPUY INC
Product Code
KWA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

BACK IN 2007, I HAD A HIP REPLACEMENT BY DR (B)(6). THE DEVICE USED WAS A DEPUY PINNACLE METAL ON METAL DEVICE. MONTHS AFTER THE SURGERY, I WAS SUFFERING HORRIBLE PAIN AND COULD BARELY WALK AROUND THE BLOCK. I HAD TO USE A CANE AND EVENTUALLY I WAS ALMOST NOT AMBULATORY IN THE REGULAR SENSE THAT ONE IS ABLE. I WAS PUT OFF BY DEPUY AND OTHERS SAYING THAT IT WAS ONLY THE ASR THAT WERE BEING RECALLED. YEARS WENT ON THE SUFFERING WORSE IN ADDITION TO HORRIBLE BACK PAINS JUST ABOVE THE HIP AREA. MY FAMILY DR SENT ME TO HAVE A TEST FOR HIGH CHROMIUM/COBALT LEVELS. WHEN WE GET THE TEST BACK THE COBALT LEVEL WAS VERY HIGH AND THOUGH NOT AS HIGH THE CHROMIUM WAS ABOVE NORMAL LEVELS. I MIGHT ADD THAT IN 2009, I SUFFERED FROM A CASE OF TINNITUS. AT THE TIME I WAS NOT AWARE, BUT NOW I READ RESEARCH THAT INDICATED THAT HIGH COBALT LEVELS CAN CAUSE TINNITUS. I HAVE SINCE HAD REPLACEMENT SURGERY DONE BY DR (B)(6). (B)(6) MONTHS PAST THE SURGERY, I CAN WALK WITH NO HIP PAIN. WE RETESTED MY BLOOD AND THE COBALT LEVEL DOWN TO ALMOST BELOW EXPECTED LEVEL. I STILL AM SUFFER MUSCLE PAIN AND AM NOT SURE HOW MUCH PERMANENT DAMAGE WAS DONE. DEPUY HAS SENT ME FORM TO INVESTIGATE THIS. I AM FEARFUL BECAUSE I DON'T HAVE A LAWYER THEY MAY JUST IGNORE THIS. (B)(6) OF FDA SUGGESTED I MAKE THIS COMPLAINT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEPUY INC DEPUY PINNACLE METAL ON METAL HIP REPLACEMENT KWA DEPUY INC PINNACLE METAL ON

Patients

Seq Age Sex Outcome Treatment
1 62 YR Hospitalization| R| S