FDA Adverse Event
Other
Summary report: N
REVERSE SHOULDER SYSTEM
MDR report key: 1001898
·
Received February 25, 2008
Report
- Report Number
- 1644408-2008-00050
- Event Type
- Other
- Date Received
- February 25, 2008
- Date of Event
- January 29, 2008
- Report Date
- February 25, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - SHOULDER WAS DISLOCATING
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVERSE SHOULDER SYSTEM | GLENOID HEAD W/ RETAINING SCREW | HSD | ENCORE MEDICAL, L.P. | 53879557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | 508-00-032| 508-00-004 |