Catalog Number 06-2810 |
Device Problems
Detachment Of Device Component (1104); Positioning Problem (3009)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/12/2013 |
Event Type
malfunction
|
Event Description
|
It was reported that there was a 28 c-taper head that was coming off the stem, was not secure, surgeon used different head.
|
|
Manufacturer Narrative
|
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report.Not returned.
|
|
Manufacturer Narrative
|
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.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 no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
|
|
Event Description
|
It was reported that there was a 28 c-taper head that was coming off the stem, was not secure, surgeon used different head.
|
|
Search Alerts/Recalls
|