This follow-up report is being submitted to relay additional information.The following sections were updated: correction: complaint sample was evaluated and the reported event was confirmed.The femoral stem packaging was returned and from the returned package evaluation determined that, the inner and outer cavities were cracked on the cavity flange, outer cavity was damaged and the outer carton box shows the transit damage.Device history record was reviewed and no discrepancies were found.The cracked cavities damage can be caused due to the outside forces during transit or the forces due to the implant.As it's unknown how many times it has been in shipping and it was in the field for a long time, the root cause for the reported issue is attributed to be transit damage.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.
|