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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 06/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.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 - 05411; 0001825034 - 2018 - 05412; 0001825034 - 2018 - 05413.
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Event Description
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It was reported that approximately 1 month post implantation, the patient underwent an i&d due to non-healing wound.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.Concomitant medical products: item # 650-1057, head, lot # unk, item # unk, shell, lot # unk, item # unk, liner, lot # unk, item # 650-1064, taper, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09760.
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Search Alerts/Recalls
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