(b)(4).Cagri ors, md, remzi caylak, md, emre togrul, md.(16 june 2021).Total hip arthroplasty with the wagner cone femoral stem in patients with crowe iv developmental dysplasia of the hip: a retrospective study, 37 (2022) 103-109.Https://doi.Org/10.1016/j.Arth.2021.09.007.Report source: foreign report source: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
|
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|