Batch review performed on 28 october 2020: lot 124320: (b)(4) items manufactured and released on 11-jan-2013.Expiration date: 2017-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Preliminary investigation performed on 30 october 2020 by medacta hip project manager: from the photos it appeared that the stem was totally without ha coating, which was completely absorbed, index of a good osseo-integration; moreover, bone and blood were present in the distal and diaphyseal part of the stem.From the received photos it was not possible to determine the root cause of the event.Clinical evaluation performed on 30 october 2020 by medacta medical affairs manager: femoral component revision surgery performed 7 years and 7 months after primary cementless total hip arthroplasty in a (b)(6) year old, heavy ((b)(6) kg) woman.Radiographic images provided show the presence of a subsided stem.This may be due to a slight stem undersizing.The reason of this choice cannot be assessed not having preoperative images.Patient weight may also have contributed to this event.The reason of this failure cannot be determined.
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