FDA Adverse Event
Death
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 4491250
·
Received February 6, 2015
Report
- Report Number
- 0002249697-2015-00256
- Event Type
- Death
- Date Received
- February 6, 2015
- Date of Event
- July 8, 2014
- Report Date
- January 19, 2015
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN STRYKER HIP. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REVISED ON OR ABOUT (B)(6) 2013 WITH UNKNOWN STRYKER PRODUCTS (COUNSEL CLAIMS THAT IT COULD HAVE BEEN A POST-RECALL IMPLANTATION OF ABGII MODULAR). COUNSEL CLAIMS THAT THE DECEASED HAD EXTREMELY HIGH LEVELS OF COBALT IN HER BLOOD AND DIED OF "COBALT TOXICITY" DECEASED DIED ON (B)(6) 2014
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86014 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |