FDA Adverse Event
Other
Summary report: N
RSP SHOULDER SYSTEM
MDR report key: 1172659
·
Received September 15, 2008
Report
- Report Number
- 1644408-2008-00324
- Event Type
- Other
- Date Received
- September 15, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSD
- PMA / PMN Number
- K041066
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - PATIENT HAD POOR RANGE OF MOTION AND PAIN. X-RAY LOOKED ABNORMAL, UNABLE TO TELL WHAT WAS WRONG FROM X-RAY ALONE. DURING REVISION, RSP HUMERAL SOCKET, SHELL, AND GLENOID HEAD WERE REMOVED FOR BETTER EXPOSURE AND TO ACCESS THE POSITION AND STABILITY OF BASE PLATE. DOCTOR STATED BASE PLATE FIXATION WAS ACCEPTABLE AND THAT THE HUMERAL SOCKET WAS PLACED IN THE WRONG POSITION INITIALLY. ONE SCREW WAS PLACED IN THE BASEPLATE, NEW GLENOID HEAD IMPLANTED, AND NEW HUMERAL SOCKET AND SHELL WERE PLACED IN BETTER POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER SYSTEM | HUMERAL SOCKET INSERT | HSD | ENCORE MEDICAL, L.P. | 53799309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | 508-00-000/53864969| 508-32-101/53851095 |