FDA Adverse Event
Other
Summary report: N
FOUNDATION SHOULDER
MDR report key: 2931663
·
Received January 24, 2013
Report
- Report Number
- 1644408-2013-00031
- Event Type
- Other
- Date Received
- January 24, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSD
- PMA / PMN Number
- K950594
- 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 PT HAD A TOTAL SHOULDER DONE ABOUT 10 YRS AGO ADN NOW THE PT IS UNDERGOING A REVERSE SHOULDER PROSTHESIS DUE TO A FAILED TOTAL SHOULDER ROTATOR CUFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33782 | FOUNDATION SHOULDER | STANDARD HUMERAL HEAD | HSD | ENCORE MEDICAL, L.P. | 53772102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | 503-03-012, LOT 602622| 500-04-150, LOT 601092 |