Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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"literature article entitled, ¿cemented versus uncemented hemiarthroplasty for displaced femoral neck fractures¿ by wender figved md, et al, published by clinical orthopaedic related research (2009), vol.467, pp.2426-2435, was reviewed.The purpose of this article is to compare the results of cemented versus uncemented hemiarthroplasties implanted into the frail elderly after a displaced femoral neck fracture.This complaint will capture the initial study results as well as the results of the 5 year follow up.Implanted depuy products: all patient received a depuy bipolar head (mobile bipolar head and cocr modular head).The cemented group was implanted with a competitor stem secured with competitor cement.The cementless group was implanted with a corail femoral stem.Results: the authors provide a detailed list of patients and postoperative outcomes.These cases are detailed within the guidance document labeled case 1-case 16.This parent complaint will capture the deaths noted in the study and the additional results provided within the 5 year follow up.There were 4 deaths that occurred within 72 hours of the index operation.One patient experienced a severe decrease in blood pressure during the cementing procedure and died within 24 hours owing to an acute myocardial infarction.This death is attributed to the competitor cement and will not be included in this complaint.Another patient in the cemented group experienced cardiac arrest during wound closure and died of a myocardial infarction within 72 hours.The only depuy product used in this procedure was the depuy bipolar head- the stem and the cement were competitor products.2 patients died of respiratory failure within 72 hours of index surgery.In the five-year follow-up, the authors note there were 3 additional periprosthetic femoral fractures treated with internal fixation.Captured in (b)(4): mobile bipolar head, cocr modular head, and corail stem: death.Corail stem: no reported product problem.Patient harms: myocardial infarction, cardiac arrest, respiratory failure, fracture post op, surgical intervention.The corail stem will not be coded for cardiac arrest and myocardial infarction because this implant was not used in the cemented procedure.Case 1 through case 16 are linked to (b)(4).(b)(6) yo female implanted with hemiarthroplasty including competitor stem, depuy bipolar head (mobile bipolar head and cocr modular head).Dislocation treated with open reduction 2 days postoperatively.Patient re-dislocated the next day and was converted to a tha with competitor acetabular products and unknown acetabular fixation device.The bipolar head was left in situ.
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