(b)(4).Report source: (b)(6).The device will not be returned for analysis, as the device was implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 the event was confirmed with photographs received.Visual examination of the provided pictures identified the ring laying on the back table and not assembled to the freedom constrained liner as noted in the complaint description.A review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event.A definitive root cause cannot be determined for the liner not seating, however seating the liner without the provided ring is considered off-label use.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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