Internal complaint reference: case (b)(4).Wade, r., & shah, k.A.(2020).Functional and radiological outcome of uncemented total hip arthroplasty in young adults-5 year follow-up.Journal of orthopaedics, 18, 237-239.Doi: https://doi.Org/10.1016/j.Jor.2019.10.014.
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Additional information: d10.H3, h6: in the literature article of wade et al.2019 [1], it was reported that 1 patient suffered from a calcar fracture during a primary total hip replacement surgery with the polar system.The devices, used in treatment, were not returned for investigation and the part and batch number of the reported complaint are not known.Therefore, it is not possible to investigate whether the reported devices met manufacturing specification upon release for distribution.The severity and the failure mode are covered through our risk management.A thorough medical investigation could not be performed due to insufficient information.The reported failure mode "hip fracture" is stated as a potential adverse device effect in the hip instruction for use of smith and nephew (lit.No.12.23 ed.03/21).Based on the performed investigations, the failure mode and the relationship between the devices and the reported events cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event and it is not possible to perform a review of past corrective actions.No probable cause can be determined and no further actions will be taken to this date.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.[1]: roshan wade, kunal ajitkumar shah, functional and radiological outcome of uncemented total hip arthroplasty in young adults - 5 year follow-up, journal of orthopaedics, volume 18, 2020, pages 237-239, issn 0972-978x, https://doi.Org/10.1016/j.Jor.2019.10.014.
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