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Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: operative report states ¿indications for procedure: right hip pain despite appropriate non operative treatment.Physical examination and radiographs consistent with loosening of his right femoral component and polyethylene wear¿.There is no evidence of altr, trunnionosis, elevated cobalt or chromium ions, or mars mri findings to suggest adverse reaction of this patient to the components.With a ceramic head, this is unlikely to be involved in altr.In this morbidly obese patient with multiple system serious medical problems, symptomatic lumbar and knee arthritis, diabetic neuropathy, and multiple chronic medication requirements, failure and/or delay of biologic fixation was not surprising.Initial post-operative x-rays suggest an undersized femoral component was implanted and the use of a prophylactic dall-miles cablesuggests reluctance to implant a large femoral component, as well as possible difficulty of exposure in this morbidly obese patient, may have contributed to the subsidence noted in the five-month post-operative x-ray and contributed to the apparent failure of biologic fixation of the femoral component.The apparent failure of biologic fixation may also have been contributed to by, for example, hypothyroidism and renal disease, and medications which can all adversely affect bony ingrowth.In retrospect, a cemented femoral component would have been preferable in this case.There is no evidence that this clinical situation resulted from factors related to component manufacturing or materials.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.Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: operative report states ¿indications for procedure: right hip pain despite appropriate non operative treatment.Physical examination and radiographs consistent with loosening of his right femoral component and polyethylene wear¿.There is no evidence of altr, trunnionosis, elevated cobalt or chromium ions, or mars mri findings to suggest adverse reaction of this patient to the components.With a ceramic head, this is unlikely to be involved in altr.In this morbidly obese patient with multiple system serious medical problems, symptomatic lumbar and knee arthritis, diabetic neuropathy, and multiple chronic medication requirements, failure and/or delay of biologic fixation was not surprising.Initial post-operative x-rays suggest an undersized femoral component was implanted and the use of a prophylactic dall-miles cablesuggests reluctance to implant a large femoral component, as well as possible difficulty of exposure in this morbidly obese patient, may have contributed to the subsidence noted in the five-month post-operative x-ray and contributed to the apparent failure of biologic fixation of the femoral component.The apparent failure of biologic fixation may also have been contributed to by, for example, hypothyroidism and renal disease, and medications which can all adversely affect bony ingrowth.In retrospect, a cemented femoral component would have been preferable in this case.There is no evidence that this clinical situation resulted from factors related to component manufacturing or materials.Device not returned.
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