Model Number N/A |
Device Problem
Improper Chemical Reaction (2952)
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Patient Problem
No Information (3190)
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Event Date 10/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign.The event occurred in (b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the bone cement unexpectedly took more than 20 minutes to set, delaying surgery.No patient consequences or additional information have been reported.
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Manufacturer Narrative
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This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found the batch took too long to harden.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a manufacturing issue.Corrective action has been initiated to address reported issue.A summary of the investigation has been sent to the complainant.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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