An event regarding loosening involving a triathlon ts tibial augment was reported.The event was confirmed through clinician review of the revision operative notes provided.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms the revision surgery of the tka femoral and tibial components occurred, however, the root cause cannot be determined as insufficient information was available.I am basing my confirmation of femoral and tibial component loosening primarily off of statements made in the surgeon¿s operative report.The surgeon does not specify the individual parts composing the tka components.When the augments, stems and femoral and/or tibial components are assembled intra-operatively they essentially become monolithic.By default, if one part of the monolithic composite is seen to be loose the entirety of the parts can be considered to be loose.-device history review: 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 reported lot.Conclusion: the femoral and baseplate loosening was confirmed through clinician review of the revision operative notes provided.A review of the provided medical records by a clinical consultant stated the following: review of these records confirms the revision surgery of the tka femoral and tibial components occurred, however, the root cause cannot be determined as insufficient information was available.I am basing my confirmation of femoral and tibial component loosening primarily off of statements made in the surgeon¿s operative report.The surgeon does not specify the individual parts composing the tka components.When the augments, stems and femoral and/or tibial components are assembled intra-operatively they essentially become monolithic.By default, if one part of the monolithic composite is seen to be loose the entirety of the parts can be considered to be loose.Additional information including progress notes, pre-revision x-rays and evaluation of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned.
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