FDA Adverse Event
Injury
Summary report: N
TM MULTI HOLE ACETABULAR SHELL
MDR report key: 3080039
·
Received April 24, 2013
Report
- Report Number
- 1822565-2013-00702
- Event Type
- Injury
- Date Received
- April 24, 2013
- Report Date
- March 25, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN. A SUBLUXED ACETABULAR COMPONENT AND MIGRATED SCREW WERE ALSO FOUND ALONG WITH POSSIBLE LOOSENING. A REVISION SURGERY WAS PLANNED, BUT IS UNK IF IT WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176425 | TM MULTI HOLE ACETABULAR SHELL | KWZ | ZIMMER, INC. | 61273469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATALOG #00625006530, LOT #61288024,| SELF TAPPING BONE SCREW:| MANUFACTURED BY ZIMMER B.V., PONCE, PR |