FDA Adverse Event
Other
Summary report: N
FOUNDATION SHOULDER SYSTEM
MDR report key: 1202879
·
Received October 17, 2008
Report
- Report Number
- 1644408-2008-00375
- Event Type
- Other
- Date Received
- October 17, 2008
- Date of Event
- September 29, 2008
- Report Date
- October 1, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K950651
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PATIENT HAD A TSA PERFORMED IN 2008, WHICH FAILED DUE TO A ROTATOR CUFF FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION SHOULDER SYSTEM | FS OFFSET HUMERAL HEAD | KWS | ENCORE MEDICAL, L.P. | 53885312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | 503-00-010| 500-04-142 |