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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..

DeviceNEXGEN PRC AUGMENT BLOCK POST SZ D 10MM
Generic namePROSTHESIS, KNEE
ManufacturerZIMMER BIOMET, INC.
Report number0001822565-2020-01463
Event typeInjury
Product problemY
Date received2020-04-27
Report sourceCOMPANY 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
SourceopenFDA MAUDE (device adverse events)

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