Model Number N/A |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 03/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog #: 113760, bio-mod hum head 40diax15mm, lot # 401330.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.The stem remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01546.Will be returned.
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Event Description
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It was reported that the initial operation was performed approximately a month ago.Subsequently, the head implant disassociated from the stem making the joint dislocated a week later with no pain.A revision was performed two (2) days afterward.
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Manufacturer Narrative
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(b)(4).G3: japan.Reported event was considered confirmed from the x-rays which stated that the hardware was disassociated and that there is likely dislocation of the humerus and glenoid which is related to a fractured and disassembled component of the humerus hardware.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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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No further event information available at the time of this report.
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Search Alerts/Recalls
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