After several attempts, two heads would not mate with the stem.Visual examination of the returned devices finds nothing outward to suggest product problem.The devices were produced several months apart and are not from the same lot.No other reports found against the femoral head product/lot code combinations.Additionally, research using the as400 system indicates that several pieces from the reported lots have been delivered, and, as no additional reports have been received, can be reasonably assumed implanted without issue.Information was repeatedly requested for the third femoral head and femoral stem.No information was returned.Product problem has not been identified.Based on the performed investigation, the need for corrective action has not been indicated.Monitor via trending sep-419.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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