FDA Adverse Event Injury Summary report: N

ZIMMER NATURAL KNEE SERIES GENDER SOLUTION

MDR report key: 3233882 · Received July 13, 2013

Report

Report Number
MW5030922
Event Type
Injury
Date Received
July 13, 2013
Date of Event
August 6, 2011
Report Date
July 13, 2013
Manufacturer
ZIMMER
Product Code
JWH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS TOLD I NEEDED A TOTAL R-KNEE REPLACEMENT AND WENT TO HOSPITAL ON (B)(6) 2011 AND HAD ZIMMER PUT IN MY R-KNEE. I HAVE CHECK AND IT IS NOT ON THE RECALL LIST BUT FOR 1 YEAR I WAS ALWAYS IN PAIN, MY R-KNEE GAVE AWAY A TOTAL OF 33 TIMES OF WHICH I HIT MY HEAD CAUSING A CONCUSSION, EDEMA. I AM A FIRE FIGHTER PARAMEDIC AND WAS GLAD TO HEAR THAT MOST PEOPLE HAVE ANORMAL LIFE AFTER A TKR. NOT SO, I DID MY THERAPY WITH CONVICTION BECAUSE I ALWAYS STAY IN SHAPE BECAUSE MY JOB WAS TO KEEP IN SHAPE. FOR A YEAR THIS WENT ON, MY DOCTOR STATED TO GIVE IT TIME AND HERE IS PAIN RXS. MOST RXS WERE NOT USE DUE TO I HAVE SEEN MANY PEOPLE GET ADDICTED TO THEM. I FINALLY WENT TO ANOTHER DOCTOR AND HE DID MRI AND A SCOPE, FINALLY WE TOOK OUT THE ZIMMER KNEE AND REPLACED IT WITH A STRYKER. I AM DOING BETTER BUT DUE TO SCAR TISSUE DAMAGE, I CANNOT WORK AGAIN. PEOPLE AT ZIMMER WANT TO GET A BUNCH OF PAPER WORK FOR THEM. THEY CAN DO THIS, MY NEW DOCTOR HAS DONE GREAT AND NO PAIN MEDS BUT DUE TO HAVING THE ZIMMER IN FOR SO LONG, MY KNEE WILL ONLY BEND TO 90 DEGREES. SO WHAT NEXT, I DO NOT WANT SOME OTHER PERSON TO HAVE A LIFE CHANGING EVENT AS I DID. MY NAME IS (B)(6), ZIMMER WAS PUT IN AT (B)(6) HOSPITAL (B)(6) 2011 AND TAKEN OUT (B)(6) 2012. THE DOCTOR AT (B)(6) WAS DR (B)(6). ANYTHING I SHOULD DO SHORT OF A LAWYER. MY EMAIL IS (B)(6). THANK YOU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
325195 ZIMMER NATURAL KNEE SERIES GENDER SOLUTION TOTAL KNEE REPLACEMENT - KNEE - COBALT TITANIUM JWH ZIMMER 6307-01-230
325196 ZIMMER NATURAL KNEE SERIES GENDER SOLUTION TOTAL KNEE REPLACEMENT - KNEE - COBALT TITANIUM JWH ZIMMER 61806939
325197 ZIMMER NATURAL KNEE SERIES GENDER SOLUTION TOTAL KNEE REPLACEMENT - KNEE - COBALT TITANIUM JWH ZIMMER 00-5410-016
325198 ZIMMER NATURAL KNEE SERIES GENDER SOLUTION TOTAL KNEE REPLACEMENT - KNEE - COBALT TITANIUM JWH ZIMMER 61757353

Patients

Seq Age Sex Outcome Treatment
1 59 YR Hospitalization| R| S