FDA Adverse Event
Injury
Summary report: N
DUROM US ACETABAR COMPONENT 58/52 R
MDR report key: 1131885
·
Received August 18, 2008
Report
- Report Number
- 9613350-2008-00098
- Event Type
- Injury
- Date Received
- August 18, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 16, 2008
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- 9613350-7/15/2008-001C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC. WHICH MARKETS THE DEVICES IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS ON THE FLOOR PLAYING WITH HER GRANDCHILDREN. WHEN SHE WENT TO GET UP, SHE FELT AN IMMEDIATE DISCOMFORT. SHE CAME TO DR. AND GOT AN X-RAY WHICH SHOWED THE CUP HAD MIGRATED ANTERIORLY AND INFERIORLY, AND WAS HITTING THE FEMORAL STEM. THIS WAS REVISED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM US ACETABAR COMPONENT 58/52 R | DUROM ACETABULAR COMPONENT AND METASUL LDH LA | KWA | ZIMMER GMBH | 2299092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |