TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH Adverse Event — Malfunction (MDR 0001822565-2020-01531)
TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH Adverse Event — Malfunction (MDR 0001822565-2020-01531) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC..
| Device | TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01531 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION EXHIBITS SIGNS OF REPEATED USE AND THE ANTERIOR OF THE POST FEATURE HAS FRACTURED OFF. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ ANOMALIES IDENTIFIED. INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE LIKELY ROOT CAUSE FOR THE TASP FRACTURES IS BENDING/TORSION |
| Source | openFDA MAUDE (device adverse events) |
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