TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF Adverse Event — Malfunction (MDR 0001822565-2020-01436)
TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF Adverse Event — Malfunction (MDR 0001822565-2020-01436) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC..
| Device | TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01436 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED TASP EXHIBITS SIGNS OF REPEATED USE AND THE POST FEATURE HAS FRACTURED OFF. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE LIKELY ROOT CAUSE FOR THE TASP FRACTURES IS BENDING/TORSIONAL LOADING ON THE DEVICE. A N |
| Source | openFDA MAUDE (device adverse events) |
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