Model Number N/A |
Device Problems
Separation Failure (2547); Device Operates Differently Than Expected (2913)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 12/01/2015 |
Event Type
malfunction
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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.The following sections could not be completed with the limited information provided.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.
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Event Description
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It was reported that patient underwent an unknown procedure on an unknown date.During the procedure, the inserter would not unthread from the acetabular cup.No further information has been provided.
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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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Event Description
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It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.During the procedure, the inserter would not unthread from the acetabular cup.The cup was removed from the patient and another cup 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, 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 confirmed the reported condition.Root cause of the event was most likely attributed to surgical technique.
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Search Alerts/Recalls
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