FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 2214046
·
Received August 2, 2011
Report
- Report Number
- 1644408-2011-00436
- 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT HAS HAD A SERIES OF APPROXIMATELY SIX REVISION SURGERIES DATING BACK TO THE ORIGINAL FRACTURE IN 1999. IN 2008 OR 2009, THE DOCTOR REVISED THE PT TO AN RSP FROM A FAILED HEMI. THE RSP ALSO FAILED RECENTLY AND THE DOCTOR PERFORMED THE LATEST REVISION ON HER USING A 44+8 GLENOSPHERE FOR STABILITY, A PROXIMAL HUMERAL BONE GRAFT AND A REVISION STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | GLENOID HEAD W/RETAINING SCREW, NEUTRAL | KWS | ENCORE MEDICAL, L.P. | 53851100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | 507-08-175, LOT # 53794292| 508-00-008, LOT # 53878226| 508-00-032, LOT # UNK |