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Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00430204627, b/f shoulder head, 61977465, 00432604600, trabecular metalâ¿¢ glenoid component 46 mm, 61976949.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: 0001822565 - 2018 - 02432, 0001822565 - 2018 - 02433.
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Event Description
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It was reported patient is experiencing pain, loosening, loss of range of motion, metallosis, and tissue damage six years post-implantation.No revision has been reported yet.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported patient is experiencing polyethylene wear, debris within joint, pain, loosening, loss of range of motion, metallosis, and tissue/bone damage six years post-implantation.No revision has been reported yet.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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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