Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Blood Loss (2597)
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Event Date 08/09/2016 |
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 3 of 3 mdr's filed for the same patient (reference 1825034-2016-03550/ 03551/03552).
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Event Description
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During a total hip arthroplasty, the liner could not be fully seated in shell.When the liner was impacted again, the shell was dislodged and had to be placed again.A second and third liner were attempted to be implanted; however, would not seat in the shell.A fourth liner was used to complete the procedure.There was a 1-2 hour delay in procedure as a result and the patient required a blood transfusion and antibiotic agent feeding.
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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.
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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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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the event was confirmed.Visual inspection of the liner shows damage to the liner, likely from attempted implantation and removal, confirming the complaint.With the damage, dimensional analysis could not be completed.Cmm measurement of the shell found no deviations from the print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Complaint history review identified that no further actions are required.Root cause of the event could not 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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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 intial medwatch.
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Search Alerts/Recalls
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