Article entitled ¿factors associated with dislocation after bipolar hemiarthroplasty through an (antero )lateral approach in elderly patients with a femoral neck fracture: a retrospective cohort study with a nested case¿control subanalysis of radiographic parameters¿ written by johannes karl maria fakler, markus rositzka, nicolas schopow, andreas roth, dirk zajonz, mohamed ghanem, christian kleber, and georg osterhof published in european journal of trauma and emergency surgery on (b)(6) 2022 was reviewed.The primary aim of this study was to analyze radiologic parameters that potentially identify patients at risk for dislocation after hha.512 patients (527 hips) were involved in the study.Depuy bipolar hemiprosthesis were the standard implant.Adverse events: early dislocation within 6 weeks occurred in 8/10 of patients with a dislocation without a prior fall.In two patients, a dislocation was asserted after a fall 7 and 10 weeks after surgery.Recurrent dislocation was present in 4/10 of patients.These patients underwent revision surgery to total hip arthroplasty (tha) with a cemented cup.In 4/10 of patients, closed reduction was not possible.Revision included open reduction with change of the bipolar head in two patients, change of the prosthesis stem due to malrotation in one patient, and revision to tha with a cemented cup in one patient.Two patients were treated with closed reduction with no further dislocations.After revision surgery, three patients developed a periprosthetic infection warranting additional interventions.One patient was managed with exchange of the bipolar head, jet-lavage and antibiotics, another patient with a two-staged revision tha and one patient with removal of the tha and girdlestone arthroplasty.
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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