This pc is related to (b)(4) which reports about the patient underwent the revision surgery due to the pseudotumor.This pc reports about loosening of the cup occurred and the revision performed again.After the revision surgery performed on (b)(6) 2020, the loosening of the other company¿s cup (p/n: 121780052, kyocera' product) occurred.Therefore, on (b)(6) 2021, the patient underwent the revision surgery and replacing the stem (p/n: 900531210), the head (p/n: 136532130) and the liner (p/n: 122432152).The surgery was completed, and it was unknown whether there was any surgical delay.The surgeon commented that the loosening of the cup might be caused by the pseudotumor due to mom.No further information is available.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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