FDA Adverse Event Summary report: N

*

MDR report key: 558175 · Received September 7, 2004

Report

Report Number
MW1033157
Date Received
September 7, 2004
Report Date
August 25, 2004
Manufacturer
STRYKER HOWMEDICA
Product Code
JWH
Report Source
Voluntary report
Reporter Location
VT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PT HAS HAD MAJOR PROBLEMS WITH THE LEFT KNEE. PT WANTS TO PUT THEIR MIND AT REST THAT DIFFICULT RECOVERY IS NOT ATTRIBUTED TO A DEFECTIVE OR RECALLED PART.

Description of Event or Problem · 1

ADD'L INFO REC'D FROM RPTR 05/30/06. STRYKER CORPORATION HAS NOT RESPONDED TO MY REQUEST FOR INFO. WHY IS IT SO HARD TO GET THIS PUBLIC INFO? I HAVE NOW BEEN TOLD MY KNEE HAS FAILED. I AM FACING SURGERY IN THE NEXT 6 WEEKS. I HAVE HAD MAJOR PROBLEMS WITH THE LEFT KNEE. I WANT TO PUT MY MIND A REST THAT MY DIFFICULT RECOVERY IS NOT ATTRIBUTED TO A DEFECTIVE OR RECALLED PART. I CALLED STRYKER AND I WAS CONNECTED TO A REP, LEGAL AFFAIRS ADMINISTRATION. I ASKED HER TO PROVIDE ME WITH A LIST OF ANY RECALLS FROM STRYKER. SHE INFORMED ME IT WAS NOT RELEVANT FOR ME TO HAVE THE INFO. SHE SAID THE INFO WAS AVAILABLE PUBLICLY. I ASKED HER WHERE AND SHE WOULD NOT TELL ME. I HAVE BEEN TO WWW.RECALLS.GOV AND I CANNOT FIND ANY INFO ABOUT RECALLS FOR KNEE REPLACEMENTS SYSTEM. HOWEVER, WHEN I USE A SEARCH ENGINE ON THE INTERNET I GET MANY LAW FIRMS INFORMING CONSUMERS OF RECALLS OF KNEE REPLACEMENT SYSTEMS. THIS INCLUDES PALACOS BONE CEMENT, SMITH AND NEPHEW KNEE REPLACEMENT SYSTEMS, JOHN & JOHNSON & DEPUY KNEE JOINT REPLACEMENT, SULZER KNEE IMPLANT DEVICES, JOHNSON-ELLOY SYSTEM TOTAL KNEE REPLACEMENT, ENCORE ORTHOPEDICS CORP, AND STRYKER HOWMEDICA OSTEONICS. IN ADDITION, OTHER MFRS OF KNEE IMPLANTS MAY INCLUDE THE DEFECTIVE TIBIAL BASEPLATE ARE: BIOMET ORTHOPEDICS, INC, BIOPRO, CORIN, DEPUY, ENCORE ORTHOPAEDICS, ENDOTEC, HAYES MEDICAL, HOWMEDICA INTERNATIONAL, INC, IMPLEX, JOHNSON & JOHNSON, KINAMED, LINK ORTHOPEDICS, ORTHOMET, INC, OSTEOIMPLANT TECHNOLOGY, SMITH & NEPHEW, STELKAST, STRYKER HOWMEDICA, SULZER, WHITESIDE BIOMECHANICALS, WRIGHT MEDICAL TECHNOLOGY AND ZIMMER. MY DESIRE TO GET WELL, AND A LAW FIRM CANNOT HELP ME WITH THAT. HOWEVER, THE ONLY WAY I CAN GET ADDITIONAL INFO IS BY CONTACTING A LAW FIRM. IT IS TOO BAD STRYKER DOES NOT TREAT ALL THEIR CUSTOMERS WITH SAME CONCERN AS ARNOLD PALMER. I HOPE WITHOUT ANY ADDITIONAL FRUSTRATION YOU WILL SEND ME THE INFO. I HAVE A COPY OF MY HOSP CHART AND I WANT TO MATCH THE LOT NUMBERS IN THE CHART WITH THE RECALL LIST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * * JWH STRYKER HOWMEDICA * *

Patients

Seq Age Sex Outcome Treatment
1 *