MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for WRIGHT PROFEMUR HIP manufactured by Wright Medical.
[91872195]
I had a wright metal on metal hip implant. Bilaterally in 2005. I now have to have the left hip replaced because i have had severe pain since the implant was placed. I now have high chromium and cobalt levels in my blood. Over the last 3 to 4 years, i have had memory issues, a failed business and was fired from my job. I live with severe pain every day and developed an opioid dependence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073204 |
| MDR Report Key | 7013632 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-11-06 |
| Date Added to Maude | 2017-11-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WRIGHT PROFEMUR HIP |
| Generic Name | PROFEMUR HIP |
| Product Code | KWA |
| Date Received | 2017-11-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL |
| Brand Name | WRIGHT PROFEMUR HIP |
| Generic Name | PROFEMUR HIP |
| Product Code | HXA |
| Date Received | 2017-11-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2017-11-09 |