FDA Adverse Event
Injury
Summary report: N
ACCOLADE TMZF HIP STEM #5
MDR report key: 3233025
·
Received July 18, 2013
Report
- Report Number
- 0002249697-2013-02358
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED SINCE NO DEVICE INFORMATION WAS PROVIDED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS EXPLANTED PRODUCTS, OPERATIVE REPORTS, XRAYS, PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER.
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FEMORAL HEAD DISSOCIATED FROM STEM LEADING TO REVISION 6 YEARS POST OP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FEMORAL HEAD DISSOCIATED FROM STEM LEADING TO REVISION 6 YEARS POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335744 | ACCOLADE TMZF HIP STEM #5 | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |