MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-30 for DEPUY ROTATING PLATFORM UNK NA manufactured by Johnson & Johnson.
[4070104]
In (b)(6) 2010 i had a rt knee replacement, (b)(6) 2010 had to have it manipulated, (b)(6) of 2011 had revision on rt knee, in (b)(6) of 2013 second doctor realized i was allergic to nickel in the depuy knee and had to replace the whole knee again. Not going through rehab still and not off the narcotics; yet this will be a whole new problem to deal with. It took 3 years to figure out i was allergic to the cobalt / nickel. I was only (b)(6) and in good health when this all started. Have not been able to work. Life has been hell, a simple allergy test would have prevented this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034151 |
| MDR Report Key | 3606607 |
| Date Received | 2014-01-30 |
| Date of Report | 2014-01-30 |
| Date Added to Maude | 2014-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPUY ROTATING PLATFORM |
| Generic Name | DEPUY ROTATING PLATFORM |
| Product Code | HRZ |
| Date Received | 2014-01-30 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | ROTATING PLATFORM |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-01-30 |