TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH Adverse Event — Malfunction (MDR 0001822565-2020-01500)
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH Adverse Event — Malfunction (MDR 0001822565-2020-01500) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC..
| Device | TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01500 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH PHYSICAL EVALUATION. THE RETURNED PROVISIONAL EXHIBITED SIGNS OF REPEATED USE AND WAS FRACTURED ON THE MEDIAL SIDE OF THE POST. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A CORRECTIVE AND PREVENTATIVE ACTION IN |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →