FDA Adverse Event
Injury
Summary report: N
DUROM US ACETABULAR COMPONENT 60/54 T
MDR report key: 1241738
·
Received November 24, 2008
Report
- Report Number
- 9613350-2008-00224
- Event Type
- Injury
- Date Received
- November 24, 2008
- Date of Event
- July 24, 2008
- Report Date
- October 17, 2008
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWB
- 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
INFORMATION 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 PATIENT UNDERWENT TOTAL HIP REPLACEMENT IN 2007, IN WHICH HE RECEIVED A DUROM CUP ACETABULAR COMPONENT. PATIENT REPORTS, HE HAD A STEM REVISION THE FOLLOWING MONTH BECAUSE OF LEG-LENGTH DISCREPANCY. POST-OP, PATIENT HAS BEEN EXPERIENCING PAIN AND TWELVE DAYS LATER, WAS ADVISED BY DR TO UNDERGO REVISION SURGERY. PATIENT UNDERWENT REVISION SURGERY TWO MONTHS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM US ACETABULAR COMPONENT 60/54 T | DUROM ACETABULAR COMPONENT AND METASUL LDH LA | KWB | ZIMMER GMBH | 2343803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |