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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Nausea (1970); Reaction (2414)
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Event Date 08/08/2009 |
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.Medical devices: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05830; 0001825034 - 2018 - 05831; 0001825034 - 2018 - 05833.
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Event Description
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It was reported that approximately 1 week post implantation, the patient had complaints of nausea and "skin-crawling." patient reported to the emergency room and was noted to have an allergic reaction to anesthesia.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 15-103203, taperloc stem, unk, 163667, femoral head, unk, unk, unknown e1 liner, unk.Reported event was unable to be confirmed due to limited information received from the customer.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.
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Search Alerts/Recalls
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