Catalog Number 5630-G-208 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Injury (2348)
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Event Date 11/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene component was damaged, 4 more polyethylene components failed to seat.It was later reported that the total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
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Event Description
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Stryker triathlon size 2 by 8mm thick polyethylene failed to seat in stryker triathlon pkr size 2 base plate.After first polyethylene component was damaged, 4 more polyethylene components failed to seat.It was later reported that the total surgical delay approximately 2 hours with tourniquet in use.Surgeon decided to convert the procedure to a total knee procedure.
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Manufacturer Narrative
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An event regarding seating/locking issues involving a triathlon pkr insert was reported.The event was not confirmed.Method & results: product evaluation and results: review of the device by a material analysis engineer that, ¿damage observed on insert consistent with implantation and explantation processes and common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ clinician review: not performed as this was an intraoperative event.Product 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 event could not be confirmed as the implant was returned damaged and a functional or dimensional inspection could not be conducted.Examination of the device by the material analysis engineer indicated that damage observed is consistent with implantation process.No further investigation for this event is required at this time.If the additional information is received, this investigation will be reopened and re-evaluated.
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Search Alerts/Recalls
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