A cancer patient with an oncological lesion in the femoral area underwent pf nail implantation surgery in (b)(6) for impending fracture.The weight of the patient was 95 kg, height 1.57 meters.About two months post-operatively, the patient was delivered to the emergency room.X-ray taken revealed an atraumatic peri-implant fracture above the nail, and did not indicate that the nail was broken.After three days a revision surgery was conducted, during which it was shown that the nail was broken at the mid-shaft area.The fractured nail was extracted and replaced.
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The involved nail was received and underwent an examination by the company.Examination of the nail, including microscopic visual inspection, indicated it had a fatigue fracture, probably aggravated by the patient's condition:an oncological lesion and overweight.Dimensional examination, to the extent possible, did not reveal deviation from specification.Examination of the production records of the involved device indicated the implant was manufactured according to specification.Breakage of proximal femur nails is known and documented in the literature, with reported rates that range from (b)(4).The risk of implant failure increases in case of pathological fractures, as in the described case.(1).(1) johnson na et al., risk factors for intramedullary nail breakage in proximal femoral fractures: a 10-year retrospective review.Ann r coll surg engl.2017; 99(2): 145-150.Note: originally, this report was submitted on july 13, 2022.Recently it was noted that the e-submission has failed (as indicated in the fda ack3).The error listed in ack3 has been corrected and the emdr is resubmitted.
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