FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 2001077
·
Received February 16, 2011
Report
- Report Number
- 1644408-2011-00074
- Event Type
- Other
- Date Received
- February 16, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 1, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE DETAILS ARE UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | HUMERAL SOCKET | KWS | ENCORE MEDICAL, L.P. | 53930059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4): LOT 53938542| (B)(4): LOT 53939303 |