MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-29 for PROFIX manufactured by Smith And Nephew.
[4753319]
Aseptic loosening within six months after installation surgery. No indication of an infection. Prosthesis was manufactured by smith and nephew and the model name is profix.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037532 |
| MDR Report Key | 3973004 |
| Date Received | 2014-07-29 |
| Date of Report | 2014-07-24 |
| Date of Event | 2013-10-28 |
| Date Added to Maude | 2014-08-04 |
| 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 |
| 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 | PROFIX |
| Generic Name | PROFIX |
| Product Code | HSA |
| Date Received | 2014-07-29 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH AND NEPHEW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2014-07-29 |