Catalog Number 542-11-50E |
Device Problems
Malposition of Device (2616); Device Dislodged or Dislocated (2923)
|
Patient Problem
Injury (2348)
|
Event Date 11/29/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
|
|
Event Description
|
It was reported that tha was done with trident ha shell and x3 liner and stem.The shell was dislocated in about one year after tha.Therefore, all devices were removed and revision surgery was done.The removed polyethylene liner was yellowish discolored.Update dec 17, 2018- cause of revision shell was dislocated (malposition).
|
|
Manufacturer Narrative
|
An event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: the shell was returned with the liner locked into it and with the fixation screw protruding through the screw hole.Ha coating is still present on the outer surface and there is some areas with slight bony ingrowth.Apart from this, the shell and screw appear unremarkable.-medical records received and evaluation: not performed as no medical information was received for review product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
It was reported that tha was done with trident ha shell and x3 liner and stem.The shell was dislocated in about one year after tha.Therefore, all devices were removed and revision surgery was done.The removed polyethylene liner was yellowish discolored.Update dec 17, 2018- cause of revision shell was dislocated (malposition).
|
|
Search Alerts/Recalls
|