Model Number N/A |
Device Problems
Fitting Problem (2183); Computer Operating System Problem (2898)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 10/20/2015 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: "a trained medical professional determines final implant type and size intraoperatively." "orthosize software does not determine the final size and type of hardware to be implanted.".
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Event Description
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It was reported that during an initial total hip arthroplasty procedure on an unknown date the orthosize v1.2.6 software did not correctly template the stem.The surgeon broached and attempted to implant the stem, but it did not fit.The stem was removed and the surgeon continuously broached until the appropriate size was reached.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported that during an initial total hip arthroplasty procedure on (b)(6), 2015 the orthosize v1.2.6 software templated a size 8 stem.The surgeon broached to size 8 and attempted to implant the stem; however it did not fit.The stem was removed and the surgeon continuously broached until the appropriate size was reached.A size 12 stem was implanted.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Evaluation of software found no evidence of product non-conformance.Digital implant image comparison testing was conducted and all images were accurate.A conclusive root cause of the event could not be determined.
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Search Alerts/Recalls
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