FDA Adverse Event
Injury
Summary report: N
DUROM ACETABULAR COMPONENT
MDR report key: 1192460
·
Received October 9, 2008
Report
- Report Number
- 9613350-2008-00151
- Event Type
- Injury
- Date Received
- October 9, 2008
- Date of Event
- August 15, 2008
- Report Date
- September 3, 2008
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- 9613350-07/15/2008-001C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 BY PT THAT SHE UNDERWENT A TOTAL HIP REPLACEMENT IN 2008, USING A DUROM ACETABULAR COMPONENT. POST-OP, PT EXPERIENCED PAIN AND HER SURGEON RECOMMENDED REVISION. SHE IS SCHEDULED TO BE REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM ACETABULAR COMPONENT | DUROM ACETABULAR COMPONENT AND METASUL LDH LA | KWA | ZIMMER GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |