Catalog Number 72-2-0510 |
Device Problems
Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583); Unstable (1667); Material Integrity Problem (2978); Unintended Movement (3026)
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Patient Problems
Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 08/10/2015 |
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 retained by the hospital and 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.Device not returned to the manufacturer.
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Event Description
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A/p laxity in knee.Swapped poly to thicker size.
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Manufacturer Narrative
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An event regarding instability involving a scorpio insert was reported.The event was confirmed.Method & results: -device evaluation and results: could not be performed as the subject device was not returned.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.-device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event was confirmed but the exact cause of the reported instability could not be determined.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.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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A/p laxity in knee.Swapped poly to thicker size.
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Manufacturer Narrative
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A second supplemental report is being submitted on 5/1/2017 to correct patient age and document additional patient information including date of birth.
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Event Description
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A/p laxity in knee.Swapped poly to thicker size.
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Search Alerts/Recalls
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