FDA Adverse Event
Other
Summary report: N
RSP
MDR report key: 1230269
·
Received November 7, 2008
Report
- Report Number
- 1644408-2008-00398
- Event Type
- Other
- Date Received
- November 7, 2008
- Date of Event
- October 20, 2008
- Report Date
- October 24, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSD
- PMA / PMN Number
- K041066
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PATIENT CONTINUED TO DISLOCATE AFTER SEVERAL ATTEMPTS TO TRIAL ADDITIONAL IMPLANTS. SURGEON REMOVED ALL RSP AND PUT IN A FOUNDATION HEAD ADAPTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP | GLENOID BASEPLATE | HSD | ENCORE MEDICAL, L.P. | 53801680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | 508-36-101, LOT# 53783965 |