FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 1943621
·
Received December 14, 2010
Report
- Report Number
- 1644408-2010-00661
- Event Type
- Other
- Date Received
- December 14, 2010
- Date of Event
- November 26, 2010
- Report Date
- November 26, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT DISLOCATED POST OP. WHILE THE DOCTOR WAS LOOKING OVER THE X-RAYS, IT WAS DETERMINED THAT THE GLENOID WAS NOT POSITIONED WELL, IT WAS SUPERIOR AND HAD A LOT OF INFERIOR BONE. THE HEAD, LINER, AND SOCKET WERE REMOVED AND REPLACED WITH A 36MM HEAD, 8+ SHELL, AND A 36MM SEMI-CONSTRAINED INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | HUMERAL SOCKET INSERT | KWS | ENCORE MEDICAL, L.P. | A1000000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | (B)(4), LOT# A1000004| (B)(4), LOT# 848C1024| (B)(4), LOT# A1000008 |