MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-18 for RESURFACING BASEPLATE 6638-3-607 manufactured by Howmedica,inc..
[17768710]
Pt was experiencing pain inposterior region of knee. Unknown exactly to the surgeon as to why she was hurting. He replaced the tibia components with no complications. No patella component used for bothprimary and revision cases. 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 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 | 33448-1994-00014 |
| MDR Report Key | 8718 |
| Date Received | 1994-03-18 |
| Date of Report | 1994-02-15 |
| Date of Event | 1994-01-28 |
| Date Facility Aware | 1994-02-04 |
| Report Date | 1994-02-15 |
| Date Reported to FDA | 1994-02-15 |
| Date Reported to Mfgr | 1994-02-15 |
| Date Added to Maude | 1994-10-18 |
| 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 | RESURFACING BASEPLATE |
| Generic Name | PCA PRIMARY TOTAL KNEE |
| Product Code | EEA |
| Date Received | 1994-03-18 |
| Catalog Number | 6638-3-607 |
| Lot Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 8379 |
| Manufacturer | HOWMEDICA,INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-18 |