Manufacturer narrative: the reason for this revision surgery was due to aseptic loosening.The actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.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 device was disposed of at the hospital and not made available to djo surgical for examination.Records for an investigation were not supplied.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be attainable.
|