Model Number N/A |
Device Problem
Component or Accessory Incompatibility (2897)
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Patient Problem
No Information (3190)
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Event Date 01/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur.This report is number 1 of 3 mdr's filed for the same event (reference 1825034-2016-00630 / 00632).
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Event Description
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It was reported that during an initial right hip arthroplasty on (b)(6) 2016, the surgeon was unable to seat three different liners.The impacted cup was then removed and another cup and liner were used to complete the procedure.This resulted in a 30 minute delay.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found that the product was likely conforming of to print.A dimensional analysis found dimensions out of tolerance, which is likely due to deformation caused by impaction and removal of the liner.Review of the device could not confirm the reported complaint.A conclusive root cause of the event could not be determined.
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Search Alerts/Recalls
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