FDA Adverse Event
Injury
Summary report: N
ZIMMER PERIARTICULAR HUMERAL PLATE
MDR report key: 3022656
·
Received March 22, 2013
Report
- Report Number
- 1822565-2013-00520
- Event Type
- Injury
- Date Received
- March 22, 2013
- Report Date
- February 21, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- NDF
- 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 PATIENT IS EXPERIENCING A POSSIBLE ALLERGIC REACTION. X-RAYS NOTED A BROKEN SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119441 | ZIMMER PERIARTICULAR HUMERAL PLATE | NDF | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CATALOG # UNK, LOT #UNK| CATALOG #00234800714, LOT # UNK| UNKNOWN ZIMMER SCREW| PERIARTICULAR MEDICAL HUMERAL PLATE |