It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: x3 triathlon cs ins size 4 9mm; cat # 5531g409; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Implant date updated.Reported event: an event regarding malposition involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "an ap and lateral view of a right knee is provided.It appears to be a cementless cruciate retaining triathlon tritanium total knee arthroplasty.From the x-rays provided i do not see any gross ¿malplacement.¿ lateral view shows the femoral component obliquely.[¿] as mentioned, it is difficult to implicate a device or procedure based on the facts, i have been given but theoretically if the revision was done for "malplacement," approximately a month and a half after the index surgery, then unless there was trauma, the cause would be iatrogenic with improper or inaccurate assessment of bony landmarks, alignment, and position.The implants themselves cannot be implicated.As for the root cause of "malplacement," it is almost always operative technique in nature with inaccurate assessment of bony landmarks, position, and alignment.No patient related or implant factors are implicated." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to malposition of the femoral component.A review of the provided medical information by a clinical consultant indicated: "an ap and lateral view of a right knee is provided.It appears to be a cementless cruciate retaining triathlon tritanium total knee arthroplasty.From the x-rays provided i do not see any gross ¿malplacement.¿ lateral view shows the femoral component obliquely.[¿] as mentioned, it is difficult to implicate a device or procedure based on the facts, i have been given but theoretically if the revision was done for "malplacement," approximately a month and a half after the index surgery, then unless there was trauma, the cause would be iatrogenic with improper or inaccurate assessment of bony landmarks, alignment, and position.The implants themselves cannot be implicated.As for the root cause of "malplacement," it is almost always operative technique in nature with inaccurate assessment of bony landmarks, position, and alignment.No patient related or implant factors are implicated." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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