MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-20 for ZIMMER 9028-10 manufactured by Zimmer.
[11993]
7/17/89 - pt. Had left total hip replacement12/13/93 - pt. Reports about 1 month ago he began having severe pain in the left thigh x-rays show a fractured harris cemented femoral component which has fractured at the unction of the distal and middle thirds of the stem. 2/14/93 - pt. Underwent revision of left total hip arthroplasty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17011 |
| MDR Report Key | 17011 |
| Date Received | 1994-07-20 |
| Date of Report | 1994-03-08 |
| Date of Event | 1993-11-13 |
| Date Facility Aware | 1994-02-11 |
| Report Date | 1994-03-08 |
| Date Reported to Mfgr | 1994-03-08 |
| Date Added to Maude | 1994-10-21 |
| 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 |
| 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 |
| Generic Name | HARRIS PRECOAT FEMORAL STEM |
| Product Code | JDD |
| Date Received | 1994-07-20 |
| Catalog Number | 9028-10 |
| Lot Number | 65174600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4.5 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 16944 |
| Manufacturer | ZIMMER |
| Manufacturer Address | BOGGS INDUSTRIAL PARK 1777 WEST CENTER STREET WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-20 |