FDA Adverse Event
Injury
Summary report: N
PROMOS INCLINATION SET 20MM
MDR report key: 3151268
·
Received June 7, 2013
Report
- Report Number
- 9613369-2013-00046
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- May 27, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HSD
- Removal / Correction Number
- R1001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN COMPLICATIONS IN A STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252874 | PROMOS INCLINATION SET 20MM | PROMOS INCLINATION SET 20MM | HSD | SMITH & NEPHEW, INC. | A0806862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R | (B)(4) |