Model Number N/A |
Device Problem
Shipping Damage or Problem (1570)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was found at the distribution center that the sterile packaging was deformed due to the impact of the inner stem during distribution.No adverse events have been reported as a result of the malfunction.No patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The visual inspection of the returned product identified that the sterile cavity was dented on the side.Dhr was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.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 available at the time of this report.
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Search Alerts/Recalls
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