Other mfg report numbers: same failure.Different patients.1651501-2021-00007, 1651501-2021-00008, 1651501-2021-00009.A facility reported that months after surgery, the glenosphere have been disassembled from glenoid baseplate and revision surgery was required.
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Complaint sample was not received for evaluation; however, photographs were provided.The liner is shown with the corresponding glenosphere.The liner appears to be significantly damaged, featuring gouges, cracks, and deformities on nearly all surfaces.It is expected that the damage was inflicted during the explantation surgery and/or during handling after explantation.This assumption is further supported by the x-ray images provided by the customer which do not show any damage to the liner prior to explantation.As no failure is alleged against the liner and the damage to the liner appears to have resulted after the alleged failure, this investigation could not confirm any failure for the liner.The most probable cause for early dissociation of the rss glenosphere from the baseplate is improper surgical technique due to technical errors such as low impaction force, fluid contamination of the taper, or impingement between the underside of the glenosphere and the glenoid.If the part is later returned to integra this investigation may be reopened and updated.
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