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: ricchetti et, jun bj, jin y, ho jc, patterson te, dalton je, derwin ka, iannotti jp.Relationship between glenoid component shift and osteolysis after anatomic total shoulder arthroplasty: three-dimensional computed tomography analysis.J bone joint surg am.2021 aug 4;103(15):1417-1430.Doi: 10.2106/jbjs.20.00833.Pmid: 33835109; pmcid: pmc8360268.Objective/methods/study data: in a series of 152 patients (42 walch a1, 16 a2, 7 b1, 49 b2, 29 b3, 3 c1, 3 c2, and 3 d glenoids) undergoing anatomic tsa with a polyethylene glenoid component, sequential 3d ct analysis was performed preoperatively (ct1), early postoperatively (ct2), and at a minimum 2-year follow-up (ct3).Glenoid component shift was defined as a change in component version or inclination of +-3 from ct2 to ct3.Glenoid component central anchor peg osteolysis (cpo) was assessed at ct3.Factors associated with glenoid component shift and cpo were evaluated by the authors.All glenoid components are noted to be depuy apg/steptech.The article does not discuss revisions for the findings and notes that cement is utilized in the peripheral pegs while the central peg is cementless.Cement manufacturer is not identified.Adverse event(s) and provided interventions for depuy apg/steptech glenoid: qty 78 shifting (greater than 3 degrees) of the glenoid component detected via ct scan - no treatment provided.Qty 19 patients with osteolysis noted around central peg (cpo) - no treatment provided.
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