Reported event: an event regarding infection and loosening involving a triathlon femoral component was reported.The event of infection was not confirmed.Loosening was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event date: (b)(6) 2021 (opened 06/17/2021) event description: sales rep was informed by doctor that there is a removal surgery plan on 28th june due to infected implant.Implants involved: triathlon materials reviewed: 06/10/2021: stryker pi report.Undated/unlabeled: implant sheet.Triathlon x3 size #2 cs poly 11mm (also lists a 9mm cs poly), size #3 cr femur, #2 primary tibia, symmetric patella 27mm, simplex p antibiotic.Undated: right ap/lateral knee x-rays.Gross loosening of tibia and femur.Tibia with catastrophic failure and proximal tibial fracture.Confirmation: a revision surgery and infection cannot be confirmed.Catastrophic failure and collapse of a triathlon implant construct femur and tibia can be confirmed.Root cause: a root cause cannot be ascribed without additional medical records.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 lot referenced.There has been one other similar events for the sterile lot referenced.The pi relates to infection.Conclusion: the medical review indicated: a revision surgery and infection cannot be confirmed.Catastrophic failure and collapse of a triathlon implant construct femur and tibia can be confirmed.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided. additional information including pathology reports, operative reports, progress notes, x-rays and return 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 for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Catalog numbers and lot codes of other devices listed in this report: 5531g209 x3 triathlon cs insert #2 9mm, lot lje427.5550-g-278 triathlon symmetric x3 patella, lot: he17.61969001 simplex abc ce mark 1 pck, lot: bea011.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
|