Model Number N/A |
Device Problem
Scratched Material (3020)
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Patient Problem
No Information (3190)
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Event Date 06/21/2016 |
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 preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture, and/or excessive wear." this report is number 3 of 3 mdr's filed for the same patient (reference 1825034-2016-02665 / 03018 / 03024).
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Event Description
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During a total hip arthroplasty, the surgeon was unable to seat the acetabular liner into the acetabular cup.A second liner was used, and the same issue occurred.A third liner was able to be seated, but was scratched in the process and had to be removed.It was noted that the surgeon was not using the correct instrumentation.Another liner was used to complete the procedure.There was a 30-40 minute delay in procedure.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.
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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 is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed damage to the liner from attempted implantation and removal confirming the complaint.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Investigation results concluded the most likely root cause of the event is the surgical technique not being followed.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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