Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It is reported that during revision surgery, while explanting it was difficult to remove the taper adaptor from the baseplate due to which new glenosphere was fixed on the old stuck adaptor.Sixty mins delay was noted due to this issue.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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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further actions are required.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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