FDA Adverse Event
Injury
Summary report: N
DUROM US ACETABULAR COMPONENT 54/48 N
MDR report key: 1192457
·
Received October 9, 2008
Report
- Report Number
- 9613350-2008-00148
- Event Type
- Injury
- Date Received
- October 9, 2008
- Date of Event
- August 1, 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
- 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 BY PT'S ATTORNEY THAT SHE UNDERWENT A TOTAL HIP REPLACEMENT, USING A DUROM ACETABULAR COMPONENT. POST-OP, PT EXPERIENCED PAIN, AND IN 2008, HER SURGEON RECOMMENDED REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM US ACETABULAR COMPONENT 54/48 N | DUROM ACETABULAR COMPONENT AND METASUL LDH LA | KWA | ZIMMER GMBH | 2316621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |