An event regarding altr involving an unknown secur-fit shell was reported.Rom and shell malposition was confirmed following a clinician review, altr could not be confirmed.Method & results: device evaluation and results: not performed as the device remains implanted.Medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: complex malposition of components with low inclination/high anteversion of the cup shell in combination with non appropriate use of an asymmetric liner and low implantation position of the accolade stem requiring an extra-long skirted femoral head in a previous pelvic fracture deformity contributed in concert to a high risk on impingement, evident in the mar, contributing to overload in the bearing with secondary corrosion and altr causing pain and requiring revision.Does the review identify any procedural related factors that contributed to the event? cup malposition in low effective inclination and high anteversion inappropriate use of an asymmetric liner.Low implantation position of the stem requiring a skirted femoral head for compensation with increased risk on impingement as side effect.Does the review identify any patient related factors that contributed to the event? prior pelvic deformity due to trauma no information about potential overweight condition of the patient.Device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusion: a review by a clinical consultant concluded: complex malposition of components with low inclination/high anteversion of the cup shell in combination with non appropriate use of an asymmetric liner and low implantation position of the accolade stem requiring an extra-long skirted femoral head in a previous pelvic fracture deformity contributed in concert to a high risk on impingement, evident in the mar.Additional information, including device details, return of the device, operative reports, histopathology reports, progress notes and mri scan are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.Not returned to the manufacturer.
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