STRYKER ORTHOPAEDICS-MAHWAH STD, RT HUMERAL ASSEMBLY; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
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Catalog Number 5005-002R |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problems
Injury (2348); No Information (3190)
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Event Date 03/16/2016 |
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 has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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The tea surgery was performed 3 years ago.Recently, the joint axis was dissociated from the device.Therefore, the surgeon will perform the revision surgery on (b)(6) 2016.
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Manufacturer Narrative
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An event regarding disassociation involving an solar stem was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection was done.A joint axis pin was procured and it is not related to the event.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review but stated that the x-rays confirm disassociation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: x- rays confirmed disassociation but the root cause cannot be determined.If any additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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The tea surgery was performed 3 years ago.Recently, the joint axis was dissociated from the device.Therefore, the surgeon will perform the revision surgery on (b)(6) 2016.
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Search Alerts/Recalls
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