Model Number N/A |
Device Problem
Component or Accessory Incompatibility (2897)
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Patient Problem
No Information (3190)
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Event Date 04/26/2016 |
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." (b)(4).
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Event Description
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During a procedure, the liner would not seat in the acetabular cup.The liner was attempted to be seated multiple times, resulting in a 20-30 minute delay in procedure.Another liner was used to complete the 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.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information and correct information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device was unable to confirm the reported complaint.Deformation of the device was noted.A conclusive root cause of the event could not be determined.Corrective action has been initiated to address the reported issue.
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Search Alerts/Recalls
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