FDA Adverse Event Death Summary report: N

ZIMMER LONGEVITY 56MM

MDR report key: 3104747 · Received May 7, 2013

Report

Report Number
MW5030091
Event Type
Death
Date Received
May 7, 2013
Date of Event
November 1, 2006
Report Date
March 27, 2013
Manufacturer
ZIMMER INC.
Product Code
LPH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY HUSBAND, (B)(6), WAS TOLD HE NEEDED TO HAVE A HIP REPLACEMENT. HE CHOSE TO BECOME A PATIENT OF DR (B)(6). HE HAD THE LEFT HIP REPLACED IN (B)(6) 2006 WITH A ZIMMER TRILOGY WITH A ZIMMER LONGEVITY. APPROX 1 YEAR LATER, HE DEVELOPED SYMPTOMS OF EXTREME PAIN, TROUBLE WALKING AND NIGHT SWEATS. HE ALSO WAS DIAGNOSED AS HAVING (B)(6) 6 MONTHS AFTER THE FIRST SURGERY. THE ORIGINAL LOCATION WAS ON HIS LEFT CHEEK ON HIS FACE AND THEN SPREAD INTO HIS INNER EAR, WHICH LEAD TO HIM HAVING SURGERY TO HIS EAR. THE (B)(6) CAUSED A SMALL HOLE IN HIS EARDRUM AND NEEDED TO BE REPAIRED. DUE TO THE EXTREME SYMPTOMS, HE WAS EXPERIENCING AGAIN, DR (B)(6) SUGGESTED THAT HE HAVE THE HIP REVISED, WHICH SHE DID IN (B)(6) OF 2010. IN THE EARLY MONTHS OF 2012 THE EXTREME PAIN CAME BACK. IN THE 5 AND A HALF YEARS THAT MY HUSBAND DEALT WITH THIS, HE MAY HAVE HAD 8 MONTHS OF BEING PAIN FREE. HIS QUALITY OF LIFE WAS MOST DEFINITELY EFFECTED. AFTER MANY TRIPS TO (B)(6), AND MANY VISITS TO OTHER SPECIALISTS, DR (B)(6) DECIDED SHE NEEDED TO ORDER BLOOD WORK TO DETERMINE IF HE HAD ANY METAL IN HIS SYSTEM. THE COBALT LEVEL WAS EXCEPTIONALLY HIGH AND HIS CHROMIUM LEVEL WERE ALSO ELEVATED. BECAUSE OF THIS, SHE RECOMMENDED THAT HE HAVE A THIRD SURGERY TO REPLACE HIS METAL BALL WITH A CERAMIC BALL. HIS SURGERY WAS (B)(6) 2012. A WEEK BEFORE SURGERY, HE HAD ONE DAY OF VERY EXTENSIVE CARDIAC TESTS AND PASSED THEM ALL. (B)(6) 2012, (B)(6) DIED FROM EXCESSIVE AMOUNTS OF BLOOD CLOTS IN HIS RIGHT AORTA. THE DOCTORS TRIED TO REMOVE THEM AND DURING THE PROCESS, HIS HEART QUIT BEATING, AFTER 20 MINUTES OF TRYING TO RESUSCITATE, HE PASSED AWAY. I UNDERSTAND THAT THE FDA MADE A RULING REGARDING THE ZIMMER LONGEVITY, IT WAS GIVEN A PMA. AND THAT NO SUITS CAN BE FILED AGAINST ZIMMER. I WANT THIS DOCUMENTED THAT, INDEED, THERE ARE SERIOUS PROBLEMS WITH THIS ZIMMER HIP ALSO. I AM HOPING THAT THIS WILL CAUSE FURTHER INVESTIGATING BY YOU, THE FDA, AND MAY BENEFIT OTHERS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
198822 ZIMMER LONGEVITY 56MM ACETABULAR LINER LPH ZIMMER INC.
198823 FEMORAL STEM- ML TAPER, STANDARD NECK OFFSET FEMORAL STEM KWY ZIMMER INC.
198860 ZIMMER TRILOGY SIZE 56 ACETABULAR COMPONENT LPH ZIMMER INC.
198861 FEMORAL HEAD - 32- 3.5 MM LENGTH NECK FEMORAL HEAD KWY ZIMMER INC.

Patients

Seq Age Sex Outcome Treatment
1 63 YR Death| H| L| O