FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 2214045
·
Received August 2, 2011
Report
- Report Number
- 1644408-2011-00439
- Event Type
- Other
- Date Received
- August 2, 2011
- Date of Event
- July 25, 2011
- Report Date
- July 25, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE GLENOSPHERE DISLODGED (DISASSOCIATION) FROM THE BASEPLATE CAUSING THE IMPLANT TO FAIL. THE PT SUBJECTED HIMSELF TO AN AGGRESSIVE REHAB, THEN SOMETIME AFTER HIS (B)(6) 2011 X-RAYS, WHICH WERE DETERMINED TO BE OKAY, HE LIFTED AN AIR CONDITIONER. SHORTLY AFTER (B)(6) 2011, HE BEGAN TO HAVE PAIN. HE WAS REVISED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | GLENOID HEAD | KWS | ENCORE MEDICAL, L.P. | 54041095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 508-00-004, LOT 852C1021| 508-01-044, LOT 917F1000 |