STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5515-F-501 |
Device Problems
Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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The inner tray of product 5515-f-501 lot sw4ga was stuck in the outer tray and would not come out.
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Manufacturer Narrative
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An event regarding packaging issue involving a triathlon ps fem component, cemented was reported.The event was confirmed.Method & results: device evaluation: the returned device confirmed the event as the tyvek of the inner blister was stuck to the tyvek of the outer blister.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: visual inspection of the returned device indicated the tyvek of the inner blister was stuck to the tyvek of the outer blister.However, root cause could not be determined as the packaging team confirmed that the blisters were within specs.
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Event Description
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The inner tray of product 5515-f-501 lot sw4ga was stuck in the outer tray and would not come out.
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Search Alerts/Recalls
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