FDA Adverse Event
Other
Summary report: N
HYDROSET ORTHO 5CC
MDR report key: 1613194
·
Received February 8, 2010
Report
- Report Number
- 8010177-2010-00061
- Event Type
- Other
- Date Received
- February 8, 2010
- Date of Event
- September 29, 2008
- Report Date
- September 29, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- GXP
- PMA / PMN Number
- K060763
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ROOT CAUSE UNK. POSSIBLE ROOT CAUSES: PARTS OF POWDER AND/OR LIQUID WERE LOST DURING MIXING PROCESS; OPERATING ROOM TEMPERATURE WITHOUT IFU SPECIFICATION (18-22C); PRODUCT TEMPERATURE OUT OF IFU SPECIFICATION. THE IFU CONTAINS DETAILED INFO TO MIX AND IMPLEMENT HYDROSET.
Description of Event or Problem · 1
SURGEON WAS APPLYING HYDROSET AND AS HE WAS APPLYING, PRODUCT BEGAN TO SLOWLY LOOK LIKE COTTAGE CHEESE. SURGEON TRIED TO SUCTION AROUND THE AREA, BUT THE PRODUCT JUST CRUMBLED. SURGEON DECIDED TO TAKE HYDROSET OUT OF PT, IRRIGATED, AND FINISHED SURGERY WITHOUT HYDROSET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROSET ORTHO 5CC | IMPLANT | GXP | STRYKER ORTHOPAEDICS LIMERICK | NA | H75FC002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |