FDA Adverse Event
Injury
Summary report: N
ACCOLADE TMZF HIP STEM #3
MDR report key: 2010619
·
Received February 24, 2011
Report
- Report Number
- 9616680-2011-00081
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 8, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT FELL CAUSING FEMORAL FRACTURE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE TMZF HIP STEM #3 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 27139101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Required Intervention |