FDA Adverse Event
Injury
Summary report: N
ACCOLADE TMZF HIP STEM #4
MDR report key: 2071016
·
Received April 20, 2011
Report
- Report Number
- 9616680-2011-00239
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 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
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "FEMUR BECAME LOOSE CAUSING THE PT PAIN. THE DOCTOR HAD X-RAYS AND BONE SCAN TAKEN TO VERIFY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE TMZF HIP STEM #4 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 26142102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |