CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT Adverse Event — Malfunction (MDR 0001822565-2020-01520)
CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT Adverse Event — Malfunction (MDR 0001822565-2020-01520) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC
| Device | CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01520 |
| 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 HAS FRACTURED ON THE MEDIAL SIDE OF THE POST. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ ANOMALIES IDENTIFIED. SUPPLIER DHR¿S WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES AND ONE NON-CONFORMANCE WAS FOUND. A DEFINITIVE ROOT C |
| Source | openFDA MAUDE (device adverse events) |
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