MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-07 for MORELAND CURRETTE * 6020-13 (MORELAND TRAY 2) manufactured by Depuy Orthapaedics Inc.
[19491276]
Tip of "reverse currette" broke off into femoral canal during right total hip revision. Several attempts made to recover the tip but were unsuccessful. Tip remained in femoral canal and procedure continued to completion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 566175 |
| MDR Report Key | 566175 |
| Date Received | 2005-01-07 |
| Date of Report | 2004-01-14 |
| Date of Event | 2004-01-08 |
| Report Date | 2004-01-14 |
| Date Reported to FDA | 2005-01-07 |
| Date Added to Maude | 2005-01-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORELAND CURRETTE |
| Generic Name | ORTHOPEDIC REVERSE CURRETTE |
| Product Code | FZS |
| Date Received | 2005-01-07 |
| Model Number | * |
| Catalog Number | 6020-13 (MORELAND TRAY 2) |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555961 |
| Manufacturer | DEPUY ORTHAPAEDICS INC |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE A JOHNSON JOHNSON COMPANY WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-07 |