MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-14 for KINEMATIC KNEE 6471-5-711 manufactured by Howmedica, Inc..
[19240085]
At surgery there were three pieces of polyethylene loose in the joint space. The insert was delaminating and fractured. Synovectomy was performed and cutting revealed a large cyst under the medial aspect of the tibial tray. Cyst was removed, tray remained stable so cement was used to fill the void and a replacement insert was inserted. Device 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: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33446-1993-00060 |
| MDR Report Key | 7300 |
| Date Received | 1994-01-14 |
| Date of Report | 1994-01-03 |
| Date of Event | 1993-12-30 |
| Report Date | 1994-01-03 |
| Date Reported to FDA | 1994-01-03 |
| Date Reported to Mfgr | 1994-01-03 |
| Date Added to Maude | 1994-02-15 |
| 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 | KINEMATIC KNEE |
| Generic Name | TOTAL KNEE |
| Product Code | KMB |
| Date Received | 1994-01-14 |
| Catalog Number | 6471-5-711 |
| Lot Number | KHFAAM |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6981 |
| Manufacturer | HOWMEDICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-01-14 |