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Catalog Number 110035373 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This is a combination product.(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information isfound 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 the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.This surgery was finished with backup product.No adverse health consequence has been reported as the result of the malfunction.
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Event Description
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It was reported, that the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.This surgery was finished with backup product.No adverse health consequence has been reported as the result of the malfunction.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filled to relay additional information.The pictures have been received and confirmed the event.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information isfound which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Manufacturer Narrative
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This is a combination product (b)(4).This follow-up report is being submitted to relay additional information.Several product pictures have been received and allowed to confirmed the reference and the batch of the product involved through the labels.Moreover, pictures shows two holes on the sealing, which confirmed the reported event.The product was returned and lab analysis was performed.The product analysis shows that the returned product is one cement pack.The received product comprises the outer box, the inner cement pouch, the monomer pouch and the labels.The inner cement pouch sealing is opened at the right sealing of the pouch.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding packaging : inner cement pouch open sealing: 3 complaints (3 products), this one included, have been recorded on refobacin bone cement r 1x40 japan, reference 110035373, from 01 jan 2018 to 20 dec 2021.3 complaints (3 products), this one included, have been recorded on refobacin bone cement r 1x40 japan, reference 110035373, batch z41dai2201.The investigation confirmed the reported event.An action has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier and to consider to implement actions to avoid the recurrence of this type of issue.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 the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.This surgery was finished with backup product.No adverse health consequence has been reported as the result of the malfunction.
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Search Alerts/Recalls
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