The reason for this revision surgery was device loosening.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.This complaint evaluation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.A review of the device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.As of 21 jan 2019, the records needed have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.The root cause of this complaint was a revision surgery due to loose implant.There was no information submitted with the complaint that would indicate a material, design, or manufacturing issue with the explanted part.Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted.There are no indications of a product or process issue affecting implant safety or effectiveness.
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