Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 08/19/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 36mm cocr mod hd std cat# 11-363662 lot# 814830.Tri-spike shell w/apex hl 58mm cat# 101007 lot# 157390.Epoly rlc 36mm 10deg sz25 sz25 cat# ep-105895 lot# 442240.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04195.
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Event Description
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It was reported a patient underwent a right hip revision approximately 7 days post implantation due to unknown reasons.No additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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