Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Type
Injury
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Event Description
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It was reported that the quattro link anchor is pulling out of bone partially which was noted on the mri approximately 2 (two) years after initial implantation.The patient was experiencing pain.No revision has been reported to date.Attempts have been made and the additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h6 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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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Event Description
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No further information available at the time of this report.
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Search Alerts/Recalls
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