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 |