(b)(4).Foreign country: (b)(6).The reported event was identified during review of a journal article.Brüggemann, a., mallmin, h., & hailer, n.P.(2018).Do dual-mobility cups cemented into porous tantalum shells reduce the risk of dislocation after revision surgery?, 1-8.Doi:10.1080/17453674.2018.1432927.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports 0001822565-2018-05128.
|