MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-24 for MILLER-GALANTE TOTAL KNEE 00-5780-042-13 manufactured by Zimmer, Inc..
[21381211]
Patient had indication of pain and some instability. Chips of articulating surface were found in knee joint. Only articulating surface was replaced in the surgery with the substitute. The remainder of the implants were left untouched in the patientdevice labeled for single use. Patient medical status prior to event: fair condition. 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. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32821-1992-00002 |
| MDR Report Key | 1145 |
| Date Received | 1992-08-24 |
| Date of Report | 1992-08-11 |
| Date of Event | 1992-08-06 |
| Date Facility Aware | 1992-08-06 |
| Report Date | 1992-08-11 |
| Date Reported to FDA | 1992-08-11 |
| Date Reported to Mfgr | 1992-08-06 |
| Date Added to Maude | 1992-08-31 |
| 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 TOTAL KNEE |
| Generic Name | M/G I |
| Product Code | KRQ |
| Date Received | 1992-08-24 |
| Catalog Number | 00-5780-042-13 |
| Lot Number | 63374100 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JUN-89 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1096 |
| Manufacturer | ZIMMER, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-08-24 |