Model Number NH548T |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.This is a similar device report.A similar device was sold to us.
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Event Description
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It was reported that there was an issue with a plasmacup.According to the complaint description the implants involved in this complaint could not be fixed during surgery.During the total hip replacement (thr) the reamer instrument (fs960r and fs974) was damaged and was not fixed and wandered.The acetabulum cup portion has been reamed more than previously planned.Although nh548t was implanted first, it was replaced with nt550t because it was not fixed.All implants were removed because they were probably not fixed.An other implant of a competitor company was used.A pubis fracture occured during surgery.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under aag references (b)(4).Associated medwatch-reports: 9610612-2020-00405 (400480311 - nh550t) similar device sold to us.9610612-2020-00406 (400480315 - nh548t).9610612-2020-00407 (400480317 - nh522d).
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Manufacturer Narrative
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Additional information: two involved components were added to this complaint: fs960r - orthopilot tha reamer shank mpr harris - lot unknown.Fs974 - gloves protection f/fs959r/fs960r/fs961r - lot unknown.Associated medwatch-reports: 9610612-2020-00405 (400480311 - nh550t) similar device sold to us, 9610612-2020-00407 (400480317 - nh522d).
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Manufacturer Narrative
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Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
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Search Alerts/Recalls
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