Product complaint # (b)(4).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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This complaint is from a literature source.The following literature cite has been reviewed: kaseb mh, shafiee sh, shamabadi a, aminjavaheri sa, mortazavi smj.Cementless total hip arthroplasty in haemophilia patients through direct anterior approach.Haemophilia.2021 mar;27(2):e239-e244.Doi: 10.1111/hae.14224.Epub 2021 feb 2.Pmid: 33529379.Objective and methods: authors conducted a retrospective review of 12 patients diagnosed with haemophilia, who received 14 total hip arthroplasties (tha), to assess outcomes of tha using direct anterior approach (daa) in patients with haemophilia.Patients received non-cemented hip prosthesis from one of three manufacturers, with depuy pinnacle cup and corail femoral stem being used in seven patients.Liner and femoral head details were not provided.The patients were all male, and data was provided by case number and age of the patients.Results: the mean duration of clinical follow-up was 69 months (with a range of 36 to 96 months).Survey scores were good.Only one patient with simultaneous bilateral daa tha required blood transfusion.It was observed that complications of cementless tha using daa in haemophilia patients with hip arthropathy are comparable to other surgical approaches, yet the complication of bleeding in this approach might be less.Depuy hip complications by case number: case 5: age 42, simultaneous bilateral tha, experienced severe haemorrhage, treated with blood transfusion.Case 11: age 26, intraoperative calcar femur fracture, non-displaced, treated with orif cerclage wire.
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