Catalog Number 6260-9-126 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that during a primary hip procedure, a femoral head from loaners slid on and off the stem with ease, both when placing by hand or using a pusher.Another implant was opened and used, and the surgeon was satisfied with the fixation provided.As reported by rep: "he was able to remove the head with ease by hand even after impacting it on the stem with a pusher and mallet.After a couple attempts we opened a new lfit v40 head and was able to successfully impact it on the stem." surgical delay of 5 minutes was confirmed by the rep.
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Manufacturer Narrative
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Product available to stryker.An event regarding a size/fit issue involving a metal head was reported.The event was not confirmed.Visual inspection of the returned device has nothing remarkable to report.Dimensional inspection: the device is dimensionally within specification as per inspection completed.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Material analysis: not performed as there is no indication the event is related to a material integrity issue as there is evidence from the visual inspection that there is no damage to the device.No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that during a primary hip procedure, a femoral head from loaners slid on and off the stem with ease, both when placing by hand or using a pusher.Another implant was opened and used, and the surgeon was satisfied with the fixation provided.As reported by rep: "he was able to remove the head with ease by hand even after impacting it on the stem with a pusher and mallet.After a couple attempts we opened a new lfit v40 head and was able to successfully impact it on the stem." surgical delay of 5 minutes was confirmed by the rep.
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Search Alerts/Recalls
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