Model Number 5001-0303N-S |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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The returned parts were examined both with the naked eye and under magnification.The laser marks on the head and neck were slightly misaligned by 2.1 degrees.The leading corner of the locking feature on the neck was sheared away, indicating that the stem clamp was not completely seated on the stem when the head/neck assembly was rotated to lock.This misalignment can provide a false indication that the head/neck assembly was fully seated and locked on the stem.Rotating prior to fully seating of the stem clamp on the stem can shear the corner on the neck.Additional mdrs associated with this event: mdr 3025141-2016-00142 head.Mdr 3025141-2016-00144 stem.
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Event Description
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Arh slide-loc products were implanted on (b)(6) 2016.At some point post operatively, the head/neck assembly disassociated from the stem.The parts were explanted on (b)(6) 2016.
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Manufacturer Narrative
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Incorrect lot number initially reported.All information presented in this mdr is information for the correct lot number.Additional mdrs associated with this event: 3025141-2016-00142 follow up 1: head; 3025141-2016-00144 follow up 1: stem.
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Search Alerts/Recalls
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