FDA Adverse Event
Malfunction
Summary report: N
MULTIPOLAR BIPOLAR SHELL
MDR report key: 3042559
·
Received April 4, 2013
Report
- Report Number
- 2648920-2013-00092
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 7, 2013
- Manufacturer
- ZIMMER
- Product Code
- KWY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR 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 COULD NOT INSERT THE LINER INTO THE SHELL. UPON EXAMINATION IT WAS DISCOVERED THAT THE SHELL'S LOCKING MECHANISM WAS ROTATED OUT OF IT'S PROPER "SPONT" AND WAS BENT. A DIFFERENT SHELL WAS OPENED AND IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138524 | MULTIPOLAR BIPOLAR SHELL | KWY | ZIMMER | 61558187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |