FDA Adverse Event Malfunction Summary report: N

CERAMIC ON CERAMIC HIP

MDR report key: 1872176 · Received October 13, 2010

Report

Report Number
9616680-2010-00634
Event Type
Malfunction
Date Received
October 13, 2010
Date of Event
September 23, 2010
Report Date
September 23, 2010
Manufacturer
STRYKER ORTHOPAEDICS CORK
Product Code
LZO
PMA / PMN Number
UNK
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

Description of Event or Problem · 1

IT WAS REPORTED BY THE PT THAT, "ALLEGEDLY THE PT UNDERWENT A CERAMIC HIP REPLACEMENT SURGERY ABOUT 6-8 YEARS AGO AND AFTER A FEW YEARS HIS HIP BEGAN TO SQUEAKING."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CERAMIC ON CERAMIC HIP IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA UNK

Patients

Seq Age Sex Outcome Treatment
1 UNK Other