MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-04 for HARRIS PREECOAT PLUS FEMORAL STEM, SMALL, 120MM 00-9028-010 manufactured by Zimmer, Inc.
[8906]
Precoat plus stem broke mid-stemm. Stem was implanted approximately three (3) years ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-00002 |
| MDR Report Key | 13757 |
| Date Received | 1994-05-10 |
| Date of Report | 1994-04-20 |
| Date of Event | 1994-04-14 |
| Date Facility Aware | 1994-04-14 |
| Report Date | 1994-04-20 |
| Date Reported to FDA | 1994-04-20 |
| Date Reported to Mfgr | 1994-04-20 |
| Date Added to Maude | 1994-06-06 |
| 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 | HARRIS PREECOAT PLUS FEMORAL STEM, SMALL, 120MM |
| Generic Name | HARRIS PRECOAT PLUS STEM |
| Product Code | JDD |
| Date Received | 1994-11-04 |
| Model Number | NA |
| Catalog Number | 00-9028-010 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 36 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13755 |
| Manufacturer | ZIMMER, INC |
| Manufacturer Address | 1777 W. CENTER STREET WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-05-10 |