Catalog Number 2080-0040 |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 10/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.
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Event Description
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Patient came into doctor's office complaining of pain (right), upon viewing x-rays and noticing broken screws and broken gap ring.Scheduled patient for revision surgery following day.Patient denies any falls.
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Manufacturer Narrative
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An event regarding fracture involving a restoration screw was reported.The event was confirmed.Method & results: device evaluation and results: the device was not returned for evaluation.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: a review of the x-ray by the clinician confirmed the fracture of the acetabular components.However, the exact cause of the event could not be determined as further information such as revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
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Event Description
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Patient came into doctor's office complaining of pain (right), upon viewing x-rays and noticing broken screws and broken gap ring.Scheduled patient for revision surgery following day.Patient denies any falls.
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Search Alerts/Recalls
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