FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #1
MDR report key: 2232477
·
Received August 25, 2011
Report
- Report Number
- 9616680-2011-00550
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 2, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT FELL AND FRACTURED FEMUR. DR. CABLED IT AND PUT IN NEW ACCOLADE STEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM #1 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 36287904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |