Catalog Number 110005087 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 06/15/2023 |
Event Type
Injury
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Event Description
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It was reported that during an acl reconstruction procedure, the endobutton fell out with the graft.Subsequently, the surgeon noted the implant also cut through the cortex.Attempts have been made and no further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).G2: poland
customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Examination of the returned product identified the measurements were in specification.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.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 event information is available at the time of this response.
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Search Alerts/Recalls
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