The literature article entitled, "randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting" written by michael rutherford, riaz j.K.Khan, daniel p.Fick, samantha haebich, oscar nivbrant, and thomas kozak published by international orthopaedics published online on 31 january 2019 was reviewed.The article's purpose was to assess the efficacy of the technique of using autologous impaction bone grafting to achieve better fitting femoral stems.Data was compiled from 98 participants from 2013 to 2015.Depuy corail stem was utilized in all patients.Depuy product: corail stem.Adverse events: noted early migration of femoral stem greater than 3 mm (not progressive and less than 2 years).Stem loosening (treated by revision).Intra-operative calcar fracture (treated by cerclage wire).
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached x-rays could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis 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: 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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