Catalog Number 6276-7-117 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Sticking (1597)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 06/03/2015 |
Event Type
Injury
|
Event Description
|
Revising a restoration modular to lengthen the leg.Original restoration modular was implanted on (b)(6) 2013.Surgeon attempted to separate the body from the stem using the 6278-9-070 body/stem separator, lot tace913.The tip of this broke off inside the cone body.Surgeon was able to remove broken pieces from inside the cone body using forceps.Surgeon then attempted to remove entire construct using 6260-4-090 mcreynolds distal stem adaptor lot tacl506, on the slap hammer.The thread of the mcreynolds distal stem adaptor snapped off inside the implant.Surgeon then decided to leave stem insitu and change head to 36mm +10 (item 6260-9-336 lot mlaw5e) to give extra length.Important to note, cone body screw could not be reinserted as thread from distal stem adaptor was still stuck inside implant.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of the investigation.
|
|
Manufacturer Narrative
|
(b)(6).Device history review: review of the device history records indicate devices were manufactured and accepted into final stock complaint history review: there have been no other events reported for the reported manufacturing lot the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.
|
|
Event Description
|
Revising a restoration modular to lengthen the leg.Original restoration modular was implanted on (b)(6) 2013.Surgeon attempted to separate the body from the stem using the 6278-9-070 body/stem separator, lot tace913.The tip of this broke off inside the cone body.Surgeon was able to remove broken pieces from inside the cone body using forceps.Surgeon then attempted to remove entire construct using 6260-4-090 mcreynolds distal stem adaptor lot tacl506, on the slap hammer.The thread of the mcreynolds distal stem adaptor snapped off inside the implant.Surgeon then decided to leave stem insitu and change head to 36mm +10 (item 6260-9-336 lot mlaw5e) to give extra length.Important to note, cone body screw could not be reinserted as thread from distal stem adaptor was still stuck inside implant.
|
|
Search Alerts/Recalls
|