MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-16 for KINEMATIC II ROTATING HINGE KNEE TIBIAL BEARING COMPONENT 6475-3-933 6475-3-940 manufactured by Howmedica.
[19776077]
Pt had a 20+ year severe chemical exposure. Resulted in toxic synovitis, toxic arthritis. Had total knee replacement several vears ago. This failed. It was replaced 1/31/91 with a kingematic ii total knee. On 4-23-92 this patient returned to surgery for replacement of kingematic ii total knee. The tibial part was broken. The tibial parts only were replaced. The femoral part from surgery on 1/31/91 were left in patient. Device not 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. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: component failure. Conclusion: other. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4210 |
| MDR Report Key | 4210 |
| Date Received | 1992-07-16 |
| Date of Report | 1992-04-23 |
| Date of Event | 1992-04-23 |
| Report Date | 1992-04-23 |
| Date Added to Maude | 1993-05-17 |
| 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 | KINEMATIC II ROTATING HINGE KNEE |
| Generic Name | TOTAL KNEE - TIBIAL PART |
| Product Code | KRS |
| Date Received | 1992-07-16 |
| Model Number | TIBIAL BEARING COMPONENT |
| Catalog Number | 6475-3-933 6475-3-940 |
| Lot Number | SGTVAD-9033497 SXIXC-9100707 |
| ID Number | N/A |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 01-JAN-91 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3942 |
| Manufacturer | HOWMEDICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-16 |