Model Number 5001-0109N-S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The returned slideloc was returned following explantation.The returned 9 mm standard stem was inspected under microscope.Bone cement can be seen in the grit blasted portion of the stem, along with scratches that were most likely caused by tools.Typical wear and damage can be found on the ridge of the stem from implantation and explantation.Additional mdrs associated with this event: 3025141-2020-00189: head, 3025141-2020-00190: neck.
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Event Description
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An arh slideloc radial head replacement implant was implanted in the patient on (b)(6) 2016.The implant was explanted for unknown reasons on (b)(6) 2020.
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Event Description
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An arh slideloc radial head replacement implant was implanted in the patient on (b)(6) 2016.The implant was explanted for loosening of the head on (b)(6) 2020.
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Manufacturer Narrative
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Additional mdrs associated with this event:
3025141-2020-00189 follow up 1: head, and
3025141-2020-00190 follow up 1: neck.
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Search Alerts/Recalls
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