FDA Adverse Event Malfunction Summary report: N

2243265-1999-00095

MDR report key: 256963 · Received December 22, 1999

Report

Report Number
2243265-1999-00095
Event Type
Malfunction
Date Received
December 22, 1999
Report Date
December 22, 1999
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
BE
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

CUP 2051-3056 WAS PLACED. INSERT 2041-2854 WAS PLACED IN THE CUP AND TURNED OUT TO BE TOO SMALL. THE SURGEON THEN DECIDED TO REMOVE THE CUP AND REPLACE IT BY A 2051-3058. THIS CUP COULD NOT BE PLACED PROPERLY AND THE SURGEON DECIDED TO USE A CEMENTED CUP. THE TWO CUPS AND THE INSERT HAVE BEEN RETURNED TO STRYKER. AT FIRST SIGHT, THE TWO CUPS SEEM TO BE OF THE SAME SIZE.

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other