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.Literature citation: mou p, zeng wn, chen y, zhou z.Synchronous or sequential cementless bilateral total hip arthroplasty for osseous ankylosed hips with ankylosing spondylitis.Bmc musculoskelet disord.2021 mar 24;22(1):302.Doi: 10.1186/s12891-021-04142-7.Pmid: 33761925; pmcid: pmc7988988.Objective/methods/study data: 23 patients (46 hips) were retrospectively analyzed and divided into bilateral tha synchronously (group a) and sequentially (group b).The clinical measurement, radiological assessments, and complications were compared.Independent sample t test was used for data analysis.Only one single brand (depuy) of the cementless cup and stem implants were used for all patients.The friction interfaces used included ceramic-on-ceramic (coc) or ceramic-on-polyethylene (cop), which were decided according to the age, level of activity, and patients¿ financial situation.The article does not identify which depuy products were utilized.Figure 1 depicts a man with bilateral tha with no adverse events noted but no identity of the specific depuy products utilized.Caption reports radiograph at 100 month shows no aseptic loosening or migration.Figure 2 depicts a man with single and then contralateral tha's with no adverse events and no identity of the specific depuy products utilized.Caption reports 97 month follow shows good fixation.Adverse event(s) and provided interventions: qty unknown blood transfusions administered.Qty 2 femoral fracture intraoperatively fixed with several double-loop cerclage wires - patients conducted functional exercise in bed until fracture healed.Qty 1 patient experienced hip dislocation and delay union of wound.Qty 6 heterotopic ossification.
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