MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-22 for MILLER GALANTE REFER TO SPARKS HOSPITAL SEE ABOVE manufactured by Zimmer.
[20887228]
In 1987 (exact date unknown) this patient had a miller-galante total knee performed at sparks hospital in reno, nevada. "since then he has repeated episodes of recurrent swelling in his right knee and a fair amount of pain. The patient is having quite a bit of difficulty walking and also in trying to get up from a sitting position. " on 3/5/92 this patient was admitted to oroville hospital for "revision of right total joint arthroplasty". Device labeled for single use. Patient medical status prior to event: satisfactory 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: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3373 |
| MDR Report Key | 3373 |
| Date Received | 1992-07-22 |
| Date of Report | 1992-03-20 |
| Date of Event | 1992-03-05 |
| Date Facility Aware | 1992-03-05 |
| Report Date | 1992-03-20 |
| Date Reported to FDA | 1992-03-20 |
| Date Reported to Mfgr | 1992-03-18 |
| Date Added to Maude | 1993-04-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | DESCRIPTION: TIBIAL ARTICULATING SURFACE |
| Product Code | KRS |
| Date Received | 1992-07-22 |
| Model Number | REFER TO SPARKS HOSPITAL |
| Catalog Number | SEE ABOVE |
| Lot Number | SEE ABOVE |
| ID Number | SEE ABOVE |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3145 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-22 |