Catalog Number 4035890022 |
Device Problems
Leak/Splash (1354); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign.The event occured 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 that the inner sterile packaging leaked, allowing the cement to pour out.There is no patient involvement.
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Manufacturer Narrative
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(b)(4).The product is not the combination product.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation results concluded that the reported event was likely due to product design.Corrective action has been initiated to address reported 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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Search Alerts/Recalls
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