Reported event: an event regarding crack/fracture involving an unknown ceramic head was reported.Malposition of the unknown trident shell was confirmed through a medical review.Method & results: - device evaluation and results: not performed as device was not returned.- medical records received and evaluation: a review of the provided mar and x-rays by a clinical consultant noted the following; procedure-related factors: - cup malposition in low inclination (30°) with probably a further low anteversion factor.Patient-related factors - none device-related factors: - none as also supported by mar findings.Diagnosis: - cup malposition in low inclination (30°) with probably a further low anteversion factor has contributed to abnormal biomechanics with overload in the arthroplasty with edge loading, wear scar formation and finally a fatigue type of fracture in the ceramic head.-device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusion: a clinical consultant concluded the following: cup malposition in low inclination (30°) with probably a further low anteversion factor has contributed to abnormal biomechanics with overload in the arthroplasty with edge loading, wear scar formation and finally a fatigue type of fracture in the ceramic head.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
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