Model Number N/A |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Information (3190)
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Event Date 04/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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Cmp-(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Report source: (b)(6).Concomitant products: trilogy it acetabular system shell p/n 00875304801 l/n 63344546; trilogy it acetabular system shell p/n 00875305001 l/n 63301327; continuum trilogy it acetabular systems liner p/n 00875200932 l/n 63289439.Multiple mdr reports were filed for this event.Please see associated reports: 0001822565-2017-02746, 0001822565-2017-02747, 0001822565-2017-02748, 0001822565-2017-02749.
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Event Description
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It was reported that during a hip surgery, the liner could not be seated in the shell after implainting the shell.The surgeon removed the shell and replaced it with a bigger one, and the liner still could not be seated it was reported that there was a 60 minute delay.Finally the surgery completed the procedure with a size bigger shell.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional: updated corrected and to na as the product was not implanted or explanted.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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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was not confirmed.As returned, the liners were installed in the shells.The rim of the liners sat flush with the rim of the shells indicating the liners were properly seated.The event reported for liner's not seating in the shells cannot be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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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Search Alerts/Recalls
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