Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed based on evaluation of the returned insert.Method & results: product evaluation and results: visual inspection was performed on the returned insert component confirming that the ps post is fractured.A material analysis has been performed and the report concluded that burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The post fractured from the posterior side to the anterior side due to an overload condition; an indication the insert was loaded from the posterior side.The posterior end of the medial condyle had material loss consistent with the insert loaded from the posterior side.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: x-rays of the involved knee taken a few weeks prior to revision demonstrate a cemented ps tka in normal position and alignment.There is no evidence of loosening, lysis or mechanical complication.[.] it was reported that a patient underwent revision tka surgery due to breakage of the tka tibial insert stabilizing post.However, this event cannot be confirmed as insufficient information has been received for review.Documentation which would aid in the further completion of this assessment would include: surgical implant records from the surgeries, operative report from the revision surgery, outpatient office/clinic notes, implant retrieval and material analysis.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: x-rays of the involved knee taken a few weeks prior to revision demonstrate a cemented ps tka in normal position and alignment.There is no evidence of loosening, lysis or mechanical complication.It was reported that a patient underwent revision tka surgery due to breakage of the tka tibial insert stabilizing post.However, this event cannot be confirmed as insufficient information has been received for review.Further information such as surgical implant records from the surgeries, operative report from the revision surgery and outpatient office/clinic notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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