Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system." pg.1-33.Reference journal article attached.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Initial reporter - the article was written by schuyler j halverson, mihir j desai and donald h lee.
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Event Description
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It is reported in a journal article that one patient experienced mild wrist and elbow pain and type ii radiographic lucency eleven months following left radial head arthroplasty.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.This report is number 1 of 2 mdrs filed for the same patient (reference 0001825034-2017-02591).Concomitant devices - explor 7x26mm implantable stem with screw catalog #: 11-210062 lot #: ni.A review of the complaint history determined that no further action is required.The root cause remains unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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