FDA Adverse Event
Other
Summary report: N
REVERSE SHOULDER SYSTEM
MDR report key: 1112014
·
Received August 14, 2008
Report
- Report Number
- 1644408-2008-00249
- Event Type
- Other
- Date Received
- August 14, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 22, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - PATIENT INCURRED AN INFECTION OF HER RSP INVOLVED SHOULDER. PARTS WERE REMOVED, THE PATIENT WAS IRRIGATED AND DEBRIDED AND NEW COMPONENTS WERE IMPLANTED. THE STEM AND BASEPLATE WERE FOUND TO BE SECURE AND THEREFORE DID NOT REQUIRE REPLACEMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVERSE SHOULDER SYSTEM | RSP GLENOID HEAD | KWS | ENCORE MEDICAL, L.P. | 53862308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | 508-00-032/53867248| 508-00-000/53864969 |