Model Number N/A |
Device Problems
Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is being reported by zimmer biomet as (b)(4).The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.
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Event Description
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It was reported that when the palacos bone cement's package was opened, powder spilled out.The sterile pack was not sealed.No adverse events have been reported as a result of this malfunction.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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