Literature case "risk factors for periprosthetic femur fracture and influence of femoral fixation using the mini-anterolateral approach in primary total hip arthroplasty".Author: carl l.Herndon, md et al., the journal of arthroplasty.There were 684 primary thas in this study, 57 (8.3%) pffs (periprosthetic femur fracture) occurred.It was documented on the paper that there were 12 pffs in patients with smith & nephew uncollared polarstem.
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The study of herndon et.Al.[1] reports surgeries on 684 hips.It is reported that in 12 cases patients suffered from a periprosthetic fracture.In all cases an uncollared polarstem was implanted.The part and the batch number of the devices, used in treatment, are not known.Therefore, the batch record review and a complaint history review could not be performed.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu (lit.No.12.23 ed.05/16).The severity and the failure mode are covered through the risk management.As no device was received for investigation, a visual inspection could not be performed.No patient specific information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on the conducted investigation the failure mode cannot be confirmed and the root cause of the reported issue stays undetermined due to insufficient information.To date, no further actions are deemed necessary.Smith and nephew will monitor the devices for further similar issues.[1]: herndon, carl l, jared a nowell, nana o sarpong, h.John cooper, roshan p shah, and jeffrey a geller.The journal of arthroplasty 35.3 (2020): 774-78.
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