MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-15 for MILLER GALANTE N/A 5782-70-01 manufactured by Zimmer.
[651]
Patient was undergoing surgery for a loose tibial component. When the doctor went to remove the base plate with mgii augmented base platedevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33195-1992-00001 |
| MDR Report Key | 1570 |
| Date Received | 1992-10-15 |
| Date of Report | 1992-09-29 |
| Date of Event | 1992-09-22 |
| Date Facility Aware | 1992-09-22 |
| Report Date | 1992-09-29 |
| Date Reported to FDA | 1992-09-29 |
| Date Reported to Mfgr | 1992-09-22 |
| Date Added to Maude | 1992-10-29 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | MILLER GALANTE |
| Generic Name | TOTAL KNEE BASE PLATE |
| Product Code | EEA |
| Date Received | 1992-10-15 |
| Model Number | N/A |
| Catalog Number | 5782-70-01 |
| Lot Number | 51470000 |
| ID Number | LARGE-1 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1498 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-10-15 |