The reason for this revision surgery was due to humeral 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.The healthcare professional indicated there was a 15-20 minute 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.A review of the device history records (dhr) was not conducted since the lot number was not provided or determined during the complaint evaluation.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are in need of review.Given the limited information, a search of djo records for an invoice of the previous surgery produced no results.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 made available.The root cause of this complaint was a revision surgery due to humeral loosening.There are no indications of a product or process issue affecting implant safety or effectiveness.The surgeon performed this procedure to remedy the patient's condition.This complaint will be closed with the lot number(s) unknown.Should additional information become available at a later date, the complaint will be updated.
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