MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-10 for RESURFACING BASEPLATE 9MM 6638-5-209 manufactured by Howmedica, Inc..
[21607261]
Insert severely worn. Baseplate cracked in half on the medial side. Numerous beads loosened and were imbedded in the plastic. Surgeon replaced with no complications. 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 | 33448-1993-00136 |
| MDR Report Key | 7024 |
| Date Received | 1993-11-10 |
| Date of Report | 1993-10-04 |
| Date of Event | 1993-09-15 |
| Date Facility Aware | 1993-09-20 |
| Report Date | 1993-10-04 |
| Date Reported to FDA | 1993-10-04 |
| Date Reported to Mfgr | 1993-10-04 |
| Date Added to Maude | 1993-11-30 |
| 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 9MM |
| Generic Name | PCA PRIMARY TOTAL KNEE |
| Product Code | EEA |
| Date Received | 1993-11-10 |
| Catalog Number | 6638-5-209 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6707 |
| Manufacturer | HOWMEDICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-11-10 |