FDA Adverse Event
Injury
Summary report: N
MOM HIP RESURFACE
MDR report key: 6593562
·
Received May 24, 2017
Report
- Report Number
- MW5070024
- Event Type
- Injury
- Date Received
- May 24, 2017
- Report Date
- May 24, 2017
- Manufacturer
- SMITH & NEPHEW
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
MOM HIP RESURFACE IN 2008 - REPORTED PAIN. BLOOD SHOW EXTREMELY HIGH. CHROMIUM 50.4 UG/L AND COBALT 75.6 UG/L. NO ONE CAN TELL ME WHAT LEVEL WILL BE TOXIC TO MY BODY AND CAUSE A DISEASE. I'M HOPING YOUR AGENCY HAS SOME UPDATED INFO AS TO THE TOXICITY LEVELS OF CHROME AND COBALT IN THE BLOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368793 | MOM HIP RESURFACE | MOM HIP RESURFACE | JDI | SMITH & NEPHEW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |