FDA Adverse Event
Injury
Summary report: N
PROMOS HUMERAL
MDR report key: 3140474
·
Received May 31, 2013
Report
- Report Number
- 9613369-2013-00044
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- August 27, 2009
- Report Date
- March 15, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY WAS REPORTED DUE TO THE PATIENT FALLING SIX MONTHS POSTOP AND EXPERIENCING INCREASING DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240723 | PROMOS HUMERAL | PLUS PROMOS INCLINATION SET 20 MM | HSD | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R |