MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-20 for UNK manufactured by Unk.
[19235097]
"the medial plateau portion was found to be cracked and broken along the medical anterior limb of the component part. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 241622 |
| MDR Report Key | 241622 |
| Date Received | 1999-09-20 |
| Date of Report | 1999-09-17 |
| Date of Event | 1999-08-25 |
| Date Facility Aware | 1999-08-30 |
| Report Date | 1999-09-17 |
| Date Reported to FDA | 1999-09-17 |
| Date Added to Maude | 1999-09-24 |
| 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 | UNK |
| Generic Name | TIBIAL FEMORAL COMPONENT/SCREWS |
| Product Code | JEH |
| Date Received | 1999-09-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 5 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 234099 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 1999-09-20 |