FDA Adverse Event
Malfunction
Summary report: N
CONTINUMM HB RIM IMPACTOR
MDR report key: 2013274
·
Received March 8, 2011
Report
- Report Number
- 1822565-2011-00517
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 9, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIM IMPACTOR FRACTURED DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTINUMM HB RIM IMPACTOR | HWA | ZIMMER, INC. | 61321679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |