FDA Adverse Event
Injury
Summary report: N
ZIMMER PERIARTICULAR LOCKING PLATE SCREW
MDR report key: 1980208
·
Received February 1, 2011
Report
- Report Number
- 1822565-2011-00146
- Event Type
- Injury
- Date Received
- February 1, 2011
- Date of Event
- December 16, 2010
- Report Date
- January 4, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- 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 IS REPORTED THAT THE PT WAS REVISED DUE TO FRACTURE OF THE LOCKING SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER PERIARTICULAR LOCKING PLATE SCREW | HWC | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | CATALOG #00235905045, LOT #UNK| CATALOG #00235906045, LOT #UNK| ZIMMER PERIARTICULAR LOCKING PLATE SCREW| ZIMMER PERIARTICULAR LOCKING PLATE SCREW| CATALOG #00235907045, LOT #UNK| ZIMMER PERIARTICULAR LOCKING PLATE SCREW| CATALOG #00235904045, LOT #UNK| ZIMMER PERIARTICULAR LOCKING PLATE SCREW |