MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-18 for ZIMMER, INC. 9028-55 manufactured by Zimmer, Inc..
[6279]
Broken femoral stem. Fracture at the junction of femoral allograph and femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32768-1994-00009 |
| MDR Report Key | 17255 |
| Date Received | 1994-05-18 |
| Date of Report | 1994-05-05 |
| Date of Event | 1994-05-04 |
| Date Facility Aware | 1994-05-05 |
| Report Date | 1994-05-05 |
| Date Reported to FDA | 1994-05-05 |
| Date Added to Maude | 1994-10-28 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 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 | ZIMMER, INC. |
| Generic Name | LONG STEM, MED 300MM PRECOAT |
| Product Code | JDD |
| Date Received | 1994-05-18 |
| Catalog Number | 9028-55 |
| Lot Number | 65091300 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 30 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17187 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-05-18 |