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 synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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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The literature article entitled ¿effect of tuberosity repair on functional outcome of reverse shoulder arthroplasty in proximal humerus fractures¿ written by nirmal chandra mohapatra, udit sourav sahoo, and madan mohan sahoo accepted to be published on (b)(6) 2022 in chinese journal of traumatology.The article¿s objective was to evaluate repairing the tuberosities that are generally overlooked during rsa and observe its impact on the functional outcome and shoulder scores.Delta xtend rsa was placed in 41 patients.Post operative complications included one patient with infection requiring an irrigation and debridement and antibiotics.6 patients sustained glenoid notching of sirveaux grade 2.
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