Catalog Number 623-10-36E |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
Ossification (1428)
|
Event Date 04/23/2014 |
Event Type
Injury
|
Event Description
|
It was reported that there was a revision of the hip.There was heterotropic ossification, surgeon opened the hip and changed the head and poly.Pulled the ossification away with osteotome.Accolade stem stayed implanted.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of the investigation.
|
|
Manufacturer Narrative
|
An event regarding revision involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection concluded that the returned device contain explantation damages and no remarkable marking that could lead to the cause of the revision.Medical records received and evaluation: not performed as medical records were not received for evaluation.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: complaint history review indicates that there have been no other reported events for the subject lot code.Conclusions: the exact cause of this event could not be determined based on the information available.It is not reported why the devices were revised.Further information such as device analysis, x-rays, operative reports as well as patient history and follow up notes are needed to complete the investigation for determining root cause.
|
|
Event Description
|
It was reported that there was a revision of the hip.There was heterotropic ossification, surgeon opened the hip and changed the head and poly.Pulled the ossification away with osteotome.Accolade stem stayed implanted.
|
|
Search Alerts/Recalls
|