(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).
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This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The following sections were updated/corrected updated: b4, b5, d4, g4, g7, h2, h3, h6, h10.The event was confirmed with radiographs received.Review of the available records identified the following : the medial screw is fully seated within the bone and appears to have penetrated the acetabular cup.No other complications were noted.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.
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