Model Number 5001-0303N-S |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Additional mdrs associated with this event: 3025141-2020-00197: head, 3025141-2020-00199: stem.
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Event Description
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An arh slideloc radial head replacement system was implanted in a patient.The implant was removed for unknown reasons.
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Event Description
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An arh slideloc radial head replacement system wsa implanted in a patient.The implant was removed per the patient request, as she had been in a car accident and the implant was causing stiffness and could hardly be moved.It was explanted on (b)(6) 2020.
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Manufacturer Narrative
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H3: the laser marks between the head and neck were aligned.There was deformation in the locking regions of the neck.Some deformation expected when stem and neck is locked.Additional mdrs associated with this event: 3025141-2020-00197 follow up 1: head, and 3025141-2020-00199 follow up 1: stem.
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Search Alerts/Recalls
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