Model Number N/A |
Device Problems
Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical devices: provisional articular surface size yellow/c,d 12 catalog # 00599503012 lot # 54552900.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2018-03990.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 during a trial of revision, tasp fractured and the stem tibia cracked.Attempts have been made and no further information has been provided at this time.
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Manufacturer Narrative
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(b)(4).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.No product was returned or photos provided; therefore, visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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 during a revision for infection and loosening, it was discovered that the tibial articular surface provisional was fractured and provisional stemmed tibial component was cracked.
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Search Alerts/Recalls
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