An event regarding pack damage involving simplex bone cement was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation, no photographs of the event were provided.-clinician review: no medical records were received for review with a clinical consultant.-product history review: indicated all products were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event itself could not be confirmed as insufficient information was provided.The event description indicates that the "hospital found doses wet when box was opened".Based on the information provided, it appears that this product was damaged shortly before or during delivery.The liquid monomer from the ampoule lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
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