(b)(4).Foreign country: (b)(6).The reported event was identified during review of a journal article zajonz, d., pönick, c., edel, m., möbius, r., pfeifle, c., prietzel, t., fakler, j.K.(2020).Results after surgical treatment of periprosthetic proximal femoral fractures osteosynthesis with prosthesis preservation vs.Prosthesis change.Doi:10.21203/rs.2.22168/v1.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the devices are unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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