On (b)(6) 2021, the revision surgery was performed.In the revision, after the head was removed, the surgeon tried to remove the stem, but the stem couldn¿t be removed, and it was left in the patient.The non-depuy implants were set, and the surgery was completed within 30 minutes delay.The surgeon commented that the cold welding occurred between the stem and sleeve and the working space was narrow, and he gave up using the schneider cage due to this reason.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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