Catalog Number 159557 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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Expired implant was implanted.
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Event Description
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Expired implant was implanted.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of the product label, which verified that the product was implanted 1 day after expiry date.Device history record (dhr) was reviewed and no discrepancies were found.The cause of the reported event was an unintended use error.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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