STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
|
Back to Search Results |
|
Model Number 6226-2-652 |
Device Problem
Device Damaged Prior to Use (2284)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/05/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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, during a bha, a surgeon noticed a deformed pe tab (one out of every eight).It was used as is.
|
|
Event Description
|
It was reported that, during a bha, a surgeon noticed a deformed pe tab (one out of every eight).It was used as is.
|
|
Manufacturer Narrative
|
Corrected data h4 06apr2017.Corrected to 17apr2017.Additional manufacturer narrative reported event an event regarding appearance involving a centrax duration bipolar head was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 return of the device/ packaging is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and or additional information become available to indicate further evaluation is warranted, this record will be reopened.
|
|
Search Alerts/Recalls
|
|
|