NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONEN Adverse Event — Malfunction (MDR 1822565-2008-00057)
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONEN Adverse Event — Malfunction (MDR 1822565-2008-00057) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONEN; Generic name: KNEE PROSTHESIS; Manu
| Device | NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONEN |
|---|---|
| Generic name | KNEE PROSTHESIS |
| Manufacturer | ZIMMER, INC. |
| Report number | 1822565-2008-00057 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Health Professional, Distributor |
| Narrative | IT IS REPORTED THAT THE DEVICE WAS BEING USED IN SURGERY IN 2008. IT WAS NOTICED THAT THE BAG WAS MELTED TO THE IMPLANT. THE PIECE OF PLASTIC WAS RUBBED OFF, HOWEVER, IT LEFT A HAZY SHEEN WHERE THE PLASTIC HAD ATTACHED TO THE IMPLANT. THERE WAS NOT ANOTHER DEVICE AVAILABLE, SO THE SURGEON IMPLANTED THIS ONE. |
| Source | openFDA MAUDE (device adverse events) |
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