FDA Adverse Event
Other
Summary report: N
RSP SHOULDER SYSTEM
MDR report key: 1202861
·
Received October 17, 2008
Report
- Report Number
- 1644408-2008-00365
- Event Type
- Other
- Date Received
- October 17, 2008
- Date of Event
- September 29, 2008
- Report Date
- September 29, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSD
- PMA / PMN Number
- K041066
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY- DISLOCATION, SURGEON REALIGNED AND PUT BACK TOGETHER WITH NEW IMPLANTS (EXCEPT FOR THE STEM WHICH WAS WELL FITTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER SYSTEM | GLENOID HEAD | HSD | ENCORE MEDICAL, L.P. | 600222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | 508-00-036| 508-00-008 |