MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-08 for DEPUY 6020-11 * manufactured by Depuy Orthopaedics, Inc./depuy A Johnson & Johnson Co.
[16033911]
Procedure performed: revision left femoral component, depuy, with a new depuy porous coated long stem with associated bone grafting with agf and crotons. During surgical procedure, a depuy 10mm curette from the revision tray instrument set, was being used to remove a large piece of cement when a small portion of the end of the instrument broke/knocked off in the femoral canal. It was not possible for the surgeon to remove the small piece. Many valiant attempts were made, but it was determined that it would be in the pt's best interest to discontinue further attempts to retrieve the portion. The surgeon did not want to make a window in the bone which would weaken the bone.
Patient Sequence No: 1, Text Type: D, B5
[17766038]
Add'l info rec'd from mfr 8/20/04: the product was not returned for the subject complaint. Therefore, physical examination was not possible. The product lot number was not provided so review of the device history was not possible. If the product was returned, hardness or destructive testing could have been performed. In addition, the instrument could have been microscopically evaluated to possibly determine how the tip fractured. A search of the complaint database revealed two prior reports of breakage for this instrument. The first report was received on august 11, 2000. Although the complaint was confirmed, it was attributed to heavy usage based on the overall cosmetic appearance of the instrument. The second report was received on march 13, 2003. The instrument was discarded and the lot number was not recorded. Therefore, the investigation could not verify or draw any conclusions about the reported event. Complaint trends for this instrument will continue to be monitored to determine if corrective action is indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032365 |
| MDR Report Key | 533562 |
| Date Received | 2004-06-08 |
| Date of Report | 2004-06-08 |
| Date of Event | 2004-05-27 |
| Date Added to Maude | 2004-07-13 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | DEPUY |
| Generic Name | CURETTE 10 MM |
| Product Code | FZS |
| Date Received | 2004-06-08 |
| Model Number | 6020-11 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 522833 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC./DEPUY A JOHNSON & JOHNSON CO |
| Manufacturer Address | 700 ORTHOPAEDIC DR P.O. BOX 988 WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-08 |