MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-18 for ROBERT BRIGHAM UNI-CONDYLAR KNEE - REINFORCED TIBIAL PLATEAU manufactured by Johnson & Johnson Roducts, Inc. - Orthopaedics.
[3273]
Pt. Experienced swelling of his right knee in sept, 1993. X-rays were taken which revealed a "fatigue crack" in the prosthetic component. Revision right total knee arthroplasty was done on 1/7/94. (the anterior femoral runner had completely fractured and was loose). Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure. Conclusion: device failure directly caused 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 | 8276 |
| MDR Report Key | 8276 |
| Date Received | 1994-07-18 |
| Date of Report | 1994-02-24 |
| Report Date | 1994-02-24 |
| Date Reported to FDA | 1994-02-24 |
| Date Added to Maude | 1994-08-04 |
| 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 |
| Generic Name | ROBERT BRIGHAM UNI-CONDYLAR KNEE - REINFORCED TIBIAL PLATEAU |
| Product Code | KMB |
| Date Received | 1994-07-18 |
| Lot Number | 8MM LARGE CP6Y |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7951 |
| Manufacturer | JOHNSON & JOHNSON RODUCTS, INC. - ORTHOPAEDICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-18 |