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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pulmonary Embolism (1498); Bacterial Infection (1735); Hematoma (1884)
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Event Date 08/05/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk, head, lot # unk; item # unk, shell, lot # unk; item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05133; 0001825034-2018-05134; 0001825034-2018-05135.
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Event Description
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It was reported that approximately 4 weeks post implantation, the patient presented with pulmonary embolus and after aggressive anticoagulation, the patient developed a large thigh hematoma.The patient developed drainage to the wound with obvious breakdown of the hematoma products.Subsequently, the patient underwent hip irrigation and debridement with hematoma evacuation, wound revision, and placement of wound vac.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that approximately 4 weeks post implantation, the patient presented with pulmonary embolus and after aggressive anticoagulation, the patient developed a large thigh hematoma.The patient developed drainage to the wound with obvious breakdown of the hematoma products.Subsequently, the patient underwent hip irrigation and debridement with hematoma evacuation, wound revision, and placement of wound vac.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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