Catalog Number 110035368 |
Device Problem
Improper Chemical Reaction (2952)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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It was reported that bone cement texture was airy.This cement was used on multiple cases, this was account owned and they want a credit and one for one replacement for each type of cement.This event concerns 21 products.No adverse event was reported.
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Event Description
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It was reported that bone cement was impossible to open texture was like whipped butter "fluffy".This reports investigates cement paste consistency, however returned products showed packaging issues.This issue concerns 21 products.No adverse event was reported.
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Manufacturer Narrative
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(b)(4).The product was returned and lab analysis was performed, showing packaging difficult to open.An analysis on a retained sample from the same batch has been done and the cement is conform for paste consistency.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.1 complaints, this one included, have been recorded over the batch 842cae2507.With the available information, the exact root cause of the event could not be determined.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Product returned, pending investigation.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 bone cement texture was airy.This cement was used on multiple cases, this was account owned and they want a credit and one for one replacement for each type of cement.
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Search Alerts/Recalls
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