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Model Number N/A |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi: (b)(4).Medical product: comprehensive primary stem, catalog #: 113617 lot #: 552850.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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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It was reported that the box contained a different sized product than what the label had indicated.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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Reported device is involved in initiated recall, however correction/removal reporting number has not been received.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product determined that the product is etched with the lot number that matches the outer device packaging/labeling for a comprehensive mini stem 13mm.However, dimensional analysis of the returned product determined that is consistent with comprehensive micro stem 17mm.The root cause of the reported issue is attributed to a manufacturing deficiency as it is likely that the products were comingled during cleaning prior to laser etch.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.Multiple mdr reports have been reported for this event, please see associated report: 0001825034 - 2018 - 01707.
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Search Alerts/Recalls
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