FDA Adverse Event
Other
Summary report: N
FOUNDATION SHOULDER
MDR report key: 1971897
·
Received January 19, 2011
Report
- Report Number
- 1644408-2011-00039
- Event Type
- Other
- Date Received
- January 19, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K003324
- 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 IN (B)(6) 2010. SHE FELL CAUSING A ROTATOR CUFF TEAR AND SUBSEQUENT FAILURE OF THE TSA WHICH REQUIRED A CONVERSION TO RSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION SHOULDER | HUMERAL STEM PLASMA | KWS | ENCORE MEDICAL, L.P. | 54035031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | 503-42-022, LOT 53950978| 500-04-142, LOT UNKNOWN |