Model Number N/A |
Device Problems
Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
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Patient Problems
Osteolysis (2377); No Information (3190)
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Event Date 04/25/2017 |
Event Type
Injury
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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.Reported event was unable to be confirmed as part number and lot number of device involved in the incident is unknown.Device history record review was unable to be performed as the part number and lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
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Event Description
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It was reported that patient underwent a revision due to stem loosening.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed through review of post-operative radiographs.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.Device history record review was unable to be performed as the part number and lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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