Catalog Number 690-00-28F |
Device Problems
Material Separation (1562); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 07/21/2015 |
Event Type
Injury
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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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Patient presented with a dislocated hip and disassociated acetabular insert (constrained liner).Right hip was revised to an mdm construct.Stem was a depuy cemented stem and was well fixed.No delay in surgery.Sales rep could not confirm if prior revision was of stryker product.
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Manufacturer Narrative
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An event regarding a dissociated constrained liner was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection confirmed the event.The metal liner was dissociated from the uh1 poly.Damage on the poly suggested impingement between the stem and the liner.-medical records received and evaluation: not performed as no patient medical records were provided for review.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because no patient medical records were provided for review.It was noted that the device was implanted with a competitor head and stem combination.It is possible this mixed-manufacturer combination resulted in impingement between the devices.No further conclusions can be made without additional medical records.If additional information become available, this investigation will be reopened.
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Event Description
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Patient presented with a dislocated hip and disassociated acetabular insert (constrained liner).Right hip was revised to an mdm construct.Stem was a depuy cemented stem and was well fixed.No delay in surgery.Sales rep could not confirm if prior revision was of stryker product.
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Search Alerts/Recalls
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