Correction: expiration date.An event regarding revision due to instability involving a mako insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: -device evaluation and results: the material analysis report(mar) concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records revealed "suboptimal bearing thickness after mako medial unicondylar arthroplasty contributed to early instability requiring revision surgery to increase bearing height within 1-year of primary surgery.Obesity (bmi=38) a minor secondary factor to increase general joint load levels.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event regarding revision due to instability involving a mako insert was confirmed.The mar concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Review of the medical records provided revealed suboptimal bearing thickness after mako medial unicondylar arthroplasty contributed to early instability requiring revision surgery to increase bearing height within 1-year of primary surgery.Obesity (bmi=38) a minor secondary factor to increase general joint load levels.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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