STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G609 |
Device Problems
Material Deformation (2976); Insufficient Information (3190)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/01/2016 |
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.Not returned to the manufacturer.
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Event Description
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Revision of triathlon insert and patella components.Patella was replaced due to a depression on the articular surface.Insert was replaced with an insert 4 mm thicker.
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Manufacturer Narrative
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An event regarding revision surgery for an unspecified reason involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: not performed as no medical information was provided.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as reason for the revision surgery, product evaluation, x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Revision of triathlon insert and patella components.Patella was replaced due to a depression on the articular surface.Insert was replaced with an insert 4 mm thicker.
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Search Alerts/Recalls
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