PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL Adverse Event — Malfunction (MDR 0001822565-2020-01562)
PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL Adverse Event — Malfunction (MDR 0001822565-2020-01562) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC..
| Device | PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01562 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF REPEATED USE AND IS FRACTURED ON MEDIAL SIDE OF POST. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. EVALUATION OF THE RETURNED DEVICE IDENTIFI |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →