H3, h6: it was reported that a revision surgery of polarstem stem lat.Ti/ha 1 non-cem was performed due to breakage of the stem, which intent use is in treatment.The device was returned for investigation and the fracture surfaces were analyzed.About three quarter of the fracture surface show fatigue striations, indicating that the crack propagated by fatigue and significant torsional and shear force components have likely contributed to failure.But no pores or inclusions, which could have initiated or enhanced crack growth, could be observed on the fracture surface.The provided x-rays show the broken stem along with radiolucency around the proximal portion, which is consistent with stress shielding and micromotion.This could also indicate a stress fatigue break of the stem.A thorough product history review was performed as well.No deviations found in the corresponding batch record or material certificate.For the batch number in scope no other complaint can be found.For the specific article number no similar complaint can be found.An implant fracture is a rare but known risk of a total hip endoprosthetic and mentioned in our current risk manage file and rated as low as well in our current instruction for use for hip implants.With the information provided the clinical root cause of the stem breakage cannot be confirmed.However, stress fatigue and significant torsional and shear force of the components as a result of poor bone support from stress shielding is the likely factor that lead to the micromotion and fatigue failure.It cannot be concluded that the reported stem breakage was associated with a mal-performance of the implant.The root cause can not be established.Smith + nephew will monitor this device for similar issues.The returned article will be retained.
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