Catalog Number 110010264 |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2024-00080.0002648920-2024-00081.0001822565-2024-00991.D10: cat #: 00625006550 / trilogy bone scr 6.5x50 / lost #: 63033489.Cat #: 00625006550 / trilogy bone scr 6.5x50 / lot #: 63849814.Cat #: 00625006525 / trilogy bone scr 6.5x25 / lot #: j7012414.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that a patient is being scheduled for a left hip revision approximately three months post implantation due to inadequate fixation of the cup.To date, no procedure has occurred.Attempts have been made and no further information is available.
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Event Description
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It was reported, that a patient is being scheduled for a left hip revision.Approximately, three months post implantation, due to inadequate fixation of the cup and pain.To date, no procedure has occurred.Attempts have been made.And no further information is available.
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Manufacturer Narrative
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(b)(4).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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