Catalog Number 00500104722 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It was reported that the liner was unable to be assembled to the shell.
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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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Product was not returned so no product evaluation could be conducted.Review of device history record for identified no deviations or anomalies.This device was used for treatment.A complaint history search identified no other complaints.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Root cause could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
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Search Alerts/Recalls
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