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Model Number 5001-0522R-S |
Device Problems
Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional mdrs associated with this event: 3025141-2020-00225: stem 1, 3025141-2020-00227: stem 2, 3025141-2020-00228: head 2.
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Event Description
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While implanting an arh radial head replacement system in the patient, the initial stem was found to be loose in the bone canal so the stem was upsized however the head could not be removed from the stem so a new head was used.That stem was found to be too large so it was removed and a long stem was used, along with another new head.These actions caused a one hour long delay in surgery.
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Manufacturer Narrative
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H3: the returned radial head and stem were visually inspected under magnification for any defects.According to the information given, the returned head and stem (batch information is covered by the radial head) were loose in the patient.When the surgeon tried to switch sizes they found that the head and stem were secured tightly.This is an intended function of the device.When the implant is assembled it is not designed to come apart.Additional mdrs associated with this event: 3025141-2020-00225 follow up 1: stem 1, 3025141-2020-00227: stem 2, and 3025141-2020-00228: head 2.
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Search Alerts/Recalls
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