Catalog Number 6260-5-128 |
Device Problems
Device Dislodged or Dislocated (2923); Scratched Material (3020)
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Patient Problem
No Code Available (3191)
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Event Date 03/18/2014 |
Event Type
Injury
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Event Description
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The patient was done right tha at (b)(6) 2014.The revision surgery with v40 head was done at (b)(6) 2014, because a cup and a head were dislocated.When the revision surgery, scratch was confirmed at the neck of the stem.
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Manufacturer Narrative
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A review of the photographs provided confirmed that the head dislocated from the adm poly insert, not the cup as was originally stated.The reporter indicated that the head was the only device explanted.It is not available for evaluation because it was disposed of by the hospital.Should additional information become available, it will be provided in the supplemental report upon completion of the investigation.
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Manufacturer Narrative
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An event regarding dislocation involving a cocr head was reported.The event was not confirmed.The device was not available for evaluation.Device history review.The reported device was accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.The exact cause of the event could not be determined as the devices, operative notes, clinical history and medical records are needed for further evaluation.No further investigation for this event is possible at this time.
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Event Description
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The patient was done right tha at (b)(6) 2014.The revision surgery with v40 head was done at (b)(6) 2014, because a cup and a head were dislocated.When the revision surgery, scratch was confirmed at the neck of the stem.
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Search Alerts/Recalls
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