An event regarding instability and wear involving trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.The following devices were also listed in this report: trident psl ha cluster 50mm; cat# 542-11-50e, lot# 21866401.6.5 cancellous bone screw 30mm, cat# 2030-6530-1 ; lot# 7mmmdd.6.5 cancellous bone screw 30mm, cat# 2030-6530-1 ; lot# 7mmmdd.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
|