STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 21MM X 100MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5565-S-021 |
Device Problems
Device Operates Differently Than Expected (2913); Insufficient Information (3190)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)
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Event Date 03/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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The patient was seen for post operative visits and had progressing subsidence of his tibial prosthesis as well as medial bone loss.He was scheduled for revision surgery.
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Manufacturer Narrative
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An event regarding tibial subsidence involving a triathlon stem was reported.The event was not confirmed.Method and results: -device evaluation and results: not performed as no items were returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated all devices were 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: it was reported that patient had progressing subsidence of his tibial prosthesis as well as medial bone loss.However the exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, pre- and post-operative 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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The patient was seen for post operative visits and had progressing subsidence of his tibial prosthesis as well as medial bone loss.He was scheduled for revision surgery.
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