NEXGEN PRC AUGMENT BLOCK POST SZ D 10MM Adverse Event — Injury (MDR 0001822565-2020-01463)
NEXGEN PRC AUGMENT BLOCK POST SZ D 10MM Adverse Event — Injury (MDR 0001822565-2020-01463) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NEXGEN PRC AUGMENT BLOCK POST SZ D 10MM; Generic name: PROSTHESIS, KNEE; Manufacturer: ZIMMER BIOMET, INC..
| Device | NEXGEN PRC AUGMENT BLOCK POST SZ D 10MM |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01463 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | (B)(4). THIS COMPLAINT IS NOT CONFIRMED. NO DEVICES OR PHOTOGRAPHS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. X-RAY EVALUATION BY MMI STATES THAT THE RADIOGRAPHS DEMONSTRATE ABNORMAL AREAS OF BONE MINERALIZATION/PERIPROSTHETIC LUCENCIES WHICH HAVE A SEVERAL DIFFERENTIAL |
| Source | openFDA MAUDE (device adverse events) |
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