Catalog Number 61971001 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/30/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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Glass fragment from simplex cement monomer vial found in mixed bone cement during total knee replacement.
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Manufacturer Narrative
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An event regarding glass fragments found in simplex cement mix was reported.The event was not confirmed.Method & results: -device evaluation and results: two empty ampules were returned.Photographs were provided.One of the photographs provided shows a small brown substance/particle embedded in what appears to be hardened bone cement.Two empty ampoules are also visible from the photographs, no unusual characteristics were observed from the photographs, the plastic covers/crackers were present on the top of the ampoules.-medical records received and evaluation: not performed as no medical records were provided.-device history review: the product was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding alleged glass fragment from simplex cement monomer vial found in mixed bone cement could not be confirmed.Foreign matter can be observed in the cement mix attached in the photograph provided by the customer.However only the empty ampules were returned, as the sample containing the cement mix was then discarded by the customer no material analysis of the foreign matter could be performed.Further information is required to complete this investigation and determine a root cause.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.Fm not returned.
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Event Description
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Glass fragment from simplex cement monomer vial found in mixed bone cement during total knee replacement.
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Search Alerts/Recalls
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