The literature article entitled, "outcomes after total hip arthroplasty using a cementless s-rom modular stem for patients with high hip dislocation secondary to hip pyogenic arthritis" written by yang yang, qiu-ping yu, shao-lin wang, sheng-li zhang, juan li, yi zhou, hua-quan fan, xin zhang, yu zhou, min zhou, ming-quan zhou, ning li1, and jun-li liu published by orthopaedic surgery accepted by publisher 5 may 2019 was reviewed.The article's purpose "to determine the efficiency of this strategy for tha for patients with high hip dislocation secondary to pyogenic arthritis; (ii) to evaluate the functional outcomes of patients; and (iii) to evaluate patient complications." data was compiled from 49 patients (23 men and 26 women) with age range 23-63 years old with follow ups range 5.5 - 10 years.All patients received depuy products.Depuy products utilized: pinnacle cup, srom stem, bearings of ceramic-on-ceramic or metal-on-poly adverse events: osteolysis in femur of zone 1 and/or 7 (commonly attributed to poly material implants and no mention of poly wear or debris).Stem subsidence and loosening (treated by revision of the stem).Asymptomatic heterotopic ossification (no impact to patient's function).Intraoperative femoral fracture during implantation (treated with cerclage wires).Dislocation (treated by closed reduction).Sciatic nerve paralysis (recovered within 6 months without intervention).
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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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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