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H3, h6: it was reported that a patient underwent a left primary bhr and later they were tested for elevated metal ions levels.Therefore a revision surgery was performed during which extensive cartilage loss, degeneration & effusion was found.The bhr hip was changed into a birmingham dual mobility hip with an oxinium head and polarstem.Patient was transferred from the or to regular room in stable condition.They were discharged and remained clinically stable.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and none for the cup, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.A clinical root cause could not be determined.It should be noted the acetabular component was impacted into its final position in 40 degrees abduction inclination and 25 degrees anteversion.The surgical technique (01/07 4567-0103) indicates, ¿the acetabular component is then fully impacted with 15-20° of anteversion and 40-45° inclination angle.¿ it is unknown if the increased anteversion of the acetabular component led to accelerated wear and the elevated metal ions and reported metallosis.It cannot be concluded the reported events/ clinical reactions were associated with an implant mal performance or implant failure.The patient impact beyond the reported revision could not be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
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