FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 1981202
·
Received January 26, 2011
Report
- Report Number
- 1644408-2011-00045
- Event Type
- Other
- Date Received
- January 26, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 17, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K051075
- 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 REVISION FOR A REVERSE SURGERY IN (B)(6) 2008. THE PATIENT'S PROSTHESIS RECENTLY FAILED WITH THE GLENOSPHERE DISASSOCIATING. IT WAS DETERMINED THE PATIENT WOULD BE CONVERTED TO A HEMI USING THE HEMI ADAPTER AND A FOUNDATION HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | GLENOID HEAD W/RETAINING SCREW | KWS | ENCORE MEDICAL, L.P. | 53862314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | (B)(4), LOT 53946169| (B)(4), LOT 53943848| (B)(4), LOT 53941401| (B)(4), LOT 53936351| (B)(4), LOT 5392989| (B)(4), LOT 5394766 |