Concomitant medical products: durasul®, alpha insert, ll/36, catalog#: 01.00013.712, lot#: 3097997.Mis, screwdriver for impactor (curved), catalog#: 01.00502.004, lot#: unknown.Allofit®, impactor, curved, catalog#: 01.00469.002, lot#: unknown.X-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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It was reported that: when implanting/hammering in a planned cup, the posterior acetabular wall was unfortunately fractured.Precise procedure: gradual milling of the acetabula with a rasp up to a size of 58mm in 2mm increments.Implanting a 58mm allofit cup.The posterior wall of the acetabula is fractured when the socket is hammered in.Intraoperative change to a socket roof shell with hook 60mm, additional fixation of the roof shell with countersunk screws, implantation of a cemented flat profile socket size 58mm.Patient: relatively young with a hard bone.No issues with instruments are fine.Patient outcome - bone fractured.
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