TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF Adverse Event — Malfunction (MDR 0001822565-2020-01437)
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF Adverse Event — Malfunction (MDR 0001822565-2020-01437) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC..
| Device | TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01437 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | (B)(4). UDI: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED TASP EXHIBITS SIGNS OF REPEATED USE AND HAS FRACTURED ON THE MEDIAL SIDE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IDENTIFIED THE FRACTURE WAS CONSISTENT WITH THE TASP FRACTURES ANALYZED IN A ZRM, WHICH IDENTIFIED THAT THE COMMON FAILURE MODE |
| Source | openFDA MAUDE (device adverse events) |
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