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
Component Falling (1105); Sticking (1597); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 07/19/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device remained implanted in the patient, however packaging was returned.When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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During total knee procedure, nurse went to open one of the ist inner packages, implant stuck to plastic then scrub went to assist and knee pull component out which then fell on floor.Then nurse opened final sterile package and femoral knee stuck to rubber plastic, both scrub nurse and circulating nurse had to work to get the implant 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 not confirmed.Method & results: -device evaluation and results: the packaging box with a shrink wrap partially open, the outer blister and the inner blister were returned.The implant, ifu, package insert, tyvek lids of both the inner blister and outer blister, and the foam were not returned.However, there is evidence that there was a seal in the inner and outer blisters.The inner sterile packaging looks as if it was pushed inside out.-medical records received and evaluation: not performed as medical records were not provided for review.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because the packaging was returned without the implant, the tyvek lid and the foam.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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Event Description
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During total knee procedure, nurse went to open one of the ist inner packages, implant stuck to plastic then scrub went to assist and knee pull component out which then fell on floor.Then nurse opened final sterile package and femoral knee stuck to rubber plastic, both scrub nurse and circulating nurse had to work to get the implant out.
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Search Alerts/Recalls
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