The reason for this revision surgery was reported due to loosening.The actual length of in-vivo for the items listed are 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.The devices were kept at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised items were not returned for examination and the item and or lot numbers were not provided.To adequately investigate this event, the part and or lot numbers are necessary.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to loosening.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.
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