FDA Adverse Event
Malfunction
Summary report: N
ACETABULAR HARD BEARING RIM IMPACTOR
MDR report key: 2222859
·
Received August 10, 2011
Report
- Report Number
- 1822565-2011-01817
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 14, 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
INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON WAS IMPACTING THE CERAMIC LINER INTO A TRILOGY SHELL WHEN THE DEVICE SHATTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACETABULAR HARD BEARING RIM IMPACTOR | HWA | ZIMMER, INC. | 61355427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |