Model Number N/A |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Code Available (3191)
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Event Date 06/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).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 - 2019 - 03090.
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Event Description
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It was reported that arcos interlocking stem was used and secured with screw.Proximal cone body prepared for and then trialed on the stem.Cone body got stuck on the stem.The staff was unable to remove it and had to remove interlocking stem and replace with a larger one.There was a delay of 60 min.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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Udi# (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record for the distal stem identified no deviations or anomalies would contribute to reported event.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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