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Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 06/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 010000934 g7 hi-wall e1 liner 36mm 6560469.110003621 g7 acetabular liner ceramic 32mm 6294411.Foreign report source: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02748.
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Event Description
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It was reported patient underwent an initial hip replacement.During the procedure, the g7 high wall e1 liner was inserted.After several attempts to insert the liner, it remained loose, the surgeon elected to insert a g7 acetabular liner ceramic.It was inserted flat, yet it remained crooked in the shell.This liner became stuck in the shell and could not be removed.Removal attempts resulted in a fracture of the acetabulum and removal of the shell.A larger shell was implanted.Surgery was delayed by an hour.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d10, g4, h2, h3, h6.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.One g7 hi-wall e1 liner 36mm d and one biolox delta cer lnr 32mm d were returned and evaluated.Upon visual inspection the liner is level inside of the shell.There is visible damage to the liner that can be seen when looking through the plug locations.The device could not be disassembled and no further analysis could be completed.Visible damage is noted to the rim and outside diameter of the shell typical of a device that has been tried to implant and removed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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