MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-23 for RESURFACING BASEPLATE/INSERT 6638-3-207 manufactured by Howmedica, Inc..
[4930]
Tibial insert was severely delaminated. This caused high degree of bone loss on femur, tibia, and patella area. 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. 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: yes. 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 | 33448-1993-00102 |
| MDR Report Key | 6674 |
| Date Received | 1993-09-23 |
| Date of Report | 1993-07-20 |
| Date of Event | 1993-07-02 |
| Date Facility Aware | 1993-07-20 |
| Report Date | 1993-07-20 |
| Date Reported to FDA | 1993-07-20 |
| Date Reported to Mfgr | 1993-07-20 |
| Date Added to Maude | 1993-10-07 |
| 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 | RESURFACING BASEPLATE/INSERT |
| Generic Name | PCA PRIMARY TOTAL KNEE |
| Product Code | EEA |
| Date Received | 1993-09-23 |
| Catalog Number | 6638-3-207 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6358 |
| Manufacturer | HOWMEDICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-09-23 |