Model Number N/A |
Device Problems
Positioning Failure (1158); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2022 |
Event Type
malfunction
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Event Description
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It was reported that the surgeon screwed the shell onto the cup inserter, hammered it in, saw that it was loose, pulled it out and discovered a piece of thread was torn from the inserter and remained in the shell.No delay and surgical technique was utilized.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Report source: foreign: (b)(6).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: 0001822565-2022-00709.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Straight shell inserter item 00780401520 lot 63037846 was returned for review against the complaint.Visual review of the shell inserter shows wear and tear from previous uses.Nicks, gouges, and scratches to the handle and body.The strike plate shows indentations.The threaded tip is confirmed to be fractured.Device has an approximate field age of 7 years.Device history record was reviewed and no discrepancies relevant to the reported event 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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No further event information available at the time of this report.
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Search Alerts/Recalls
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