Corrected data: common device name changed to unknown.Manufacturer narrative: the reason for this revision surgery was due to loose component.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(s) 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(s) was not provided or determined during the complaint evaluation.Given the limited information, a search for an invoice of the previous surgery produced no results.As of 7 feb 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 component.This complaint will be closed with the item and or lot number(s) unknown pending receipt of additional information.No further action is deemed necessary.
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