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).Occurred in (b)(6).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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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is the packaging being subjected to too much heat during the shrink wrap operation due to being located in the shrink wrap tunnel for an excessive amount of time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was found at the distribution center that the sterile packaging was deformed, likely due to excessive heat during the packaging process.No adverse events have been reported as a result of the malfunction.No patient involvement.No further information is available.
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Search Alerts/Recalls
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