Model Number N/A |
Device Problems
Bent (1059); Material Protrusion/Extrusion (2979)
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Patient Problem
No Code Available (3191)
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Event Date 03/18/2015 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.During the procedure, the screw head was protruding while being inserted in the acetabular cup.The screw was removed and it was noted the screw was bent.An additional hold was drilled and a new screw was utilized to complete the procedure.
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Event Description
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It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.During the procedure, the screw head was protruding while being inserted in the acetabular cup.The screw was removed and it was noted the screw was bent.An additional hold was drilled and a new screw was utilized to complete the procedure.
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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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.
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Manufacturer Narrative
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Examination of returned device found no evidence of product non-conformance.Dimensional evaluation found component to be within appropriate design specification.During the evaluation, it was noted the root cause of the event was likely due to malalignment of the screw when it was inserted into the cup.
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Search Alerts/Recalls
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