STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5517F401 |
Device Problems
Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); Osteolysis (2377)
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Event Date 09/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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"an event regarding observation of less dense bone on x-ray where the patient is asymptomatic involving a femoral component was reported.Through the investigation malposition of the femoral component was confirmed." method & results: -device evaluation and results: not performed as the components were not returned.-medical records received and evaluation: medical review indicates that: [.]"femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement,"[.]"this pi case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." -device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of the provided x-rays by a clinical consultant indicated"medical review indicates that: [.]"femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement,"[.]"this pi case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." no further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Remains implanted.
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Event Description
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Surgeon report "osteolysis"/bone appearance underneath the tibia plateau (the region underneath the plateau and about 1 cm) x-ray observation of less dense bone around the tibia prostheses during follow-up visits (3 m and 1 year) on (b)(6) 2016: as per investigation closure, medical consultant mentions the following, "less optimal position of femoral component in posterior direction, minor factor.This factor cannot be held responsible for the decrease in bmd.".
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Manufacturer Narrative
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An event regarding observation of less dense bone on x-ray where the patient is asymptomatic involving a femoral component was reported.Through the investigation malposition of the femoral component was confirmed." method & results: -device evaluation and results: not performed as the components were not returned.-medical records received and evaluation: medical review indicates that: "femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement." "this case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." -device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of the provided x-rays by a clinical consultant indicated"medical review indicates that: "femoral component is stable in the bone.X-rays confirm some notching of the femoral component due to slight posterior placement." "this case has a root cause of failure partially attributed by a procedure-related factor of less perfect position of the femoral component for which the surgeon takes responsibility possibly in combination with other thus far unknown patient-related factors with however total absence of clinical information." 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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Surgeon report "osteolysis"/bone appearance underneath the tibia plateau (the region underneath the plateau and about 1 cm).X-ray observation of less dense bone around the tibia prostheses during follow-up visits (3 m and 1 year).On 12/02/2016: as per investigation closure, medical consultant mentions the following, "less optimal position of femoral component in posterior direction, minor factor.This factor cannot be held responsible for the decrease in bmd.".
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