(b)(4).H6: tasp bottom- mechanical (g04) - provisional bottom.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use and is fractured.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A previous investigation into this issue determined that the likely root cause for the tasp fractures is bending/torsional loading on the device.A notification was sent to the field on august 7th, 2014 to provide additional clarifications relating to the instructions for use of the tasp construct for all persona users on file at the time of the field notice.Ps tasp top components and standard (non-cps) tasp bottom components have been modified to prevent fracture.The fractured tasp component in this complaint was manufactured before the design modification.The root cause is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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