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Model Number 5001-0222L-S |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional mdrs associated with this event: mdr 3025141-2016-00139 stem, mdr 3025141-2016-00140 neck.
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Event Description
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Arh slide-loc products were implanted on (b)(6) 2016.Post operatively, the head/neck assembly disassociated from the stem, potentially due to a fall experienced by the patient.The parts were explanted on (b)(6) 2016.
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Manufacturer Narrative
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The returned head, neck and stem parts were examined.The parts were received with the head and neck assembled.The laser lines on the head and the neck were aligned properly.The locking interface region on the neck was damaged.Damage to the interface was most likely caused by the stem clamp not being fulled seated on the stem prior to rotation.Lack of interference marks on the stem indicate that the head/neck assembly was not rotated to 45 degrees (the locked position).Additional mdrs associated with this event: mdr 3025141-2016-00139 stem follow up 1, mdr 3025141-2016-00140 neck follow up 1.
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Search Alerts/Recalls
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