FDA Adverse Event
Injury
Summary report: N
DURASUL BIPOLAR INSERT
MDR report key: 1151426
·
Received September 5, 2008
Report
- Report Number
- 1822565-2008-00579
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- March 18, 2008
- Report Date
- August 7, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OTHER DEVICE USED: CATALOG #440500042, BIPOLAR COCR SHELL, LOT #1613144. CATALOG #721026000, TOTAL HEAD, NEUTRAL NECK, LOT #60749505. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICES WERE IMPLANTED IN 2008. THE DEVICES WERE MIGRATING ON THE FOLLOWING MONTH, AND REACHED THE BOTTOM ON NINE DAYS LATER. THE DEVICES WERE REVISED ON THREE MONTHS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURASUL BIPOLAR INSERT | HIP PROSTHESIS | KWB | ZIMMER, INC. | NA | 60566514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |