Catalog Number 502-11-56F |
Device Problems
Failure to Disconnect (2541); Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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During the procedure, the surgeon could not disconnect the bolt from the cup.The procedure was a left total hip, not a revision.The same instrument was used to impact the second cup without any problems and the procedure was completed successfully.There was an approximate delay of 20 minutes.There was no adverse consequence to the patient or user.
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Manufacturer Narrative
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An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no information was received for review with the clinical consultant.Device history review : all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review : there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return of device are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
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Event Description
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During the procedure, the surgeon could not disconnect the bolt from the cup.The procedure was a left total hip, not a revision.The same instrument was used to impact the second cup without any problems and the procedure was completed successfully.There was an approximate delay of 20 minutes.There was no adverse consequence to the patient or user.
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Search Alerts/Recalls
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