MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-28 for HOWMEDICA CIRCONIA CERAMIC FEMORAL HEAD UNK manufactured by Howmedica.
[16146500]
The material on the ball of the hip replacement disintegrated and became infected. The hip had to be redone. There is a recall on the product 8/2001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025140 |
| MDR Report Key | 396545 |
| Date Received | 2002-05-28 |
| Date of Report | 2002-05-28 |
| Date of Event | 2002-04-09 |
| Date Added to Maude | 2002-05-30 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOWMEDICA CIRCONIA CERAMIC FEMORAL HEAD |
| Generic Name | HIP |
| Product Code | JDD |
| Date Received | 2002-05-28 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 385576 |
| Manufacturer | HOWMEDICA |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-28 |