(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02662, 0001825034-2024-00887; 0001825034-2024-00888; 0001825034-2024-00889; and 0001825034-2024-00890.D10: compr vrs glen pps min tpr adr, cat: 110027734, lot : 66157394.Unknown screw qty 2.Unknown glenosphere.Unknown bearing.G2: foreign: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
|
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h6, h10.Upon further review it has been determined that the device was previously investigated on medwatch#: 0001825034-2024-00932.This file will be considered not reportable.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.
|