MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-27 for PCA MODULAR RESURFACING BASEPLATE 7MM 6628-1-307 manufactured by Howmedica, Inc..
[3884]
Salesman called in to look aat x-rays for revision of pca tibial baseplate. According to dr. , undersized baseplate was used in original surgery which caused baseplate to subside and led to extreme loosening of the joint. Baseplate was removed and replaced with cruciform and 14mm insertdevice 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: yes. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1041641-1993-00008 |
| MDR Report Key | 6227 |
| Date Received | 1993-07-27 |
| Date of Report | 1993-06-08 |
| Date of Event | 1993-06-02 |
| Date Facility Aware | 1993-06-02 |
| Report Date | 1993-06-08 |
| Date Reported to FDA | 1993-06-08 |
| Date Reported to Mfgr | 1993-06-08 |
| Date Added to Maude | 1993-08-18 |
| 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 | PCA MODULAR RESURFACING BASEPLATE 7MM |
| Generic Name | TIBIAL BASEPLATE |
| Product Code | EEA |
| Date Received | 1993-07-27 |
| Catalog Number | 6628-1-307 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5915 |
| Manufacturer | HOWMEDICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-27 |