MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for JOHNSON & JOHNSON UNKNOWN ASXB 13 (FEMORAL) manufactured by Johnson & Johnson Orthopedics.
[6118]
Total knee replacement removed due to dislocation. On pathological exam, the articular surface of the femoral component was smooth and shiny. The articular surface of the polyethylene and metal tibial component showed slighfocal wear. Invalid data - regarding single use labeling of device. 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: end of life - premature, other. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8951 |
| MDR Report Key | 8951 |
| Date Received | 1993-07-22 |
| Date of Report | 1993-01-26 |
| Date of Event | 1992-12-21 |
| Date Facility Aware | 1992-12-21 |
| Report Date | 1993-01-26 |
| Date Reported to FDA | 1993-01-26 |
| Date Reported to Mfgr | 1993-01-26 |
| Date Added to Maude | 1994-10-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOHNSON & JOHNSON |
| Generic Name | TOTAL CONDYLAR CONTAINED KNEE |
| Product Code | KTX |
| Date Received | 1993-07-22 |
| Model Number | UNKNOWN |
| Catalog Number | ASXB 13 (FEMORAL) |
| Lot Number | UNKNOWN |
| ID Number | ASHG (TIBIAL) |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 8612 |
| Manufacturer | JOHNSON & JOHNSON ORTHOPEDICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-07-22 |