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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Impaired Healing (2378)
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Event Date 05/07/2007 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04955, 0001825034-2018-04948, 0001825034-2018-04949.
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Event Description
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It was reported that approximately 6 weeks post implantation, a patient had presented with blisters along the surgical incision.The blisters were debrided and patient was treated conservatively.Following a course of antibiotics, the wound had eschar.Subsequently, patient underwent irrigation and debridement due to eschar formation and non-healing wound.Attempts have been made, and no further information has been provided.
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Search Alerts/Recalls
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