Model Number ARS741702 |
Device Problem
Positioning Failure (1158)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 01/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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We had to revise because the morse taper from implant dwf520 and ars741702 did not engage during first revision, so surgeon wanted to make sure the morse taper mechanics were sound.Periprosthetic fracture was treated.The event was resolved with stem upsized to a 13 and a thicker tray was used as well.
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Manufacturer Narrative
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The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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We had to revise because the morse taper from implant dwf520 and ars741702 did not engage during first revision, so surgeon wanted to make sure the morse taper mechanics were sound.Periprosthetic fracture was treated.The event was resolved with stem upsized to a 13 and a thicker tray was used as well.
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Event Description
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We had to revise because the morse taper from implant dwf520 and ars741702 did not engage during first revision, so surgeon wanted to make sure the morse taper mechanics were sound.Periprosthetic fracture was treated.The event was resolved with stem upsized to a 13 and a thicker tray was used as well.
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Manufacturer Narrative
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The reported event could be confirmed.Explanted devices as well as x-rays were returned for evaluation and confirmed the event noted in this complaint.Visual inspection: the received flex tray and the flex revive stem construct both show signs of minimal wear in the form of scratches and marks to the outer areas of the devices.However, the morse taper of the tray and the mating hole of the flex revive proximal body exhibits fretting.This confirms that tray was off axis in the proximal body at some point.A review of the labeling did not indicate any abnormalities.The medical opinion of a medical expert was requested to evaluate the risk of this event: ¿without date and time stamps on the x-rays, the chronology of the events is difficult to assess.In one of the x-ray the taper seems to have separated completely form the revive stem.In another x-ray, this doesn¿t seem to be the case.Do these x-ray reflect the same point in time? for more efficient reviewing event dates are very helpful in assessing a case.¿ due to the lack of information available from the complaint reporter and the provided x-rays, the medical expert was unable to provide an adequate assessment of the case at this time.Follow up attempts with the complaint reporter has been met with no responses more information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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