MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-26 for 86-6442 8.OMM TIB./86-5400 FEM manufactured by Johnson & Johnson Products, Inc. - Orthopaedics Div..
[18138286]
The uni-condylar knee components were noted to be significantly damaged with the polyethyene quite fragmented and the baseplate of the tibial component exposed upon explantation. There was wear on the femoral component. Pieces of polyethylene was found throughout the joint. 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. 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: 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 | 7732 |
| MDR Report Key | 7732 |
| Date Received | 1994-04-26 |
| Date of Report | 1993-09-27 |
| Report Date | 1993-09-27 |
| Date Reported to Mfgr | 1993-05-13 |
| Date Added to Maude | 1994-05-16 |
| 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 | 1994-04-26 |
| Catalog Number | 86-6442 8.OMM TIB./86-5400 FEM |
| Lot Number | 059X - TIB./8579 - FEMOR. |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 01-OCT-91 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7411 |
| Manufacturer | JOHNSON & JOHNSON PRODUCTS, INC. - ORTHOPAEDICS DIV. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-26 |