Catalog Number 00875304801 |
Device Problems
Detachment Of Device Component (1104); Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 06/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported that during surgery, the shell and liner could not be implanted and well fitted.The surgery was completed with the method of cementing other devices.
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Manufacturer Narrative
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Concomitant medical product(s): 00875200832 liner elevated rim 32 mm i.D.Size gg for use with 48 mm o.D.Size gg shell 63144845.The complaint sample returned was evaluated and the complaint is confirmed.Visual inspection of the product returned shows extensive damage to the scallops, rim feature and taper so no analysis was performed.Device history records are reviewed and no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event were found, a root cause cannot be identified, with the information 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-02737.
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Event Description
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It is reported that during surgery, the shell and liner could not be implanted and well fitted.The surgery was completed with the method of cementing other devices.The liner disassociated from the cup during the range of motion.Hence the cup and liner was exchanged intra-operatively.
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Search Alerts/Recalls
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