Model Number N/A |
Device Problems
Sticking (1597); Separation Failure (2547)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/11/2015 |
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: "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling." the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.
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Event Description
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It was reported a patient underwent a hip arthroplasty on (b)(6) 2015.During the procedure, the inserter became stuck in the cup after it was inserted.The cup had to be removed from the patient.Another cup and inserter were 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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
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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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