FDA Adverse Event
Other
Summary report: N
FOUNDATION SHOULDER
MDR report key: 1943557
·
Received December 6, 2010
Report
- Report Number
- 1644408-2010-00650
- Event Type
- Other
- Date Received
- December 6, 2010
- Date of Event
- November 24, 2010
- Report Date
- November 24, 2010
- 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 PATIENT RECEIVED A TSA EARLIER THIS YEAR. SHE APPARENTLY DAMAGED HERE SUBSCAP AND REQUIRED A REVERSE. THE PREVIOUS IMPLANTS WERE REMOVED AND A REVISION WAS IMPLANTED AS INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION SHOULDER | HUMERAL HEAD | HSD | ENCORE MEDICAL, L.P. | 53973233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |