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Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-03758 / 03759 ).
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Event Description
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During a total hip arthroplasty, the liner was impacted and thought to be seated in the cup.However, during trialing and range of motion check, the liner popped out of the shell.The liner was again attempted to be impacted, but disassociated from the shell a second time.The liner was attempted to be seated a third time, with the same result.A second liner was attempted to be implanted; however, the second liner also would not seat in the shell.The shell was removed, and a new shell and liner were used to complete the procedure.There was a 15-20 minute delay in procedure.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Foreign report source: (b)(6).Concomitant medical products: item# (b)(4), g7 hi-wall e1 liner 36mm g, lot# 3530515; item# (b)(4), g7 pps ltd acet shell 58g, lot# 3813921.Complaint sample was evaluated and the reported event was confirmed.Visual inspection noted indicated no damage on the liner.Dimensional analysis on the liner did not find any related deviations/anomalies.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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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