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H3, h6: it was reported that a patient showed elevated ion levels and has also had many systemic symptoms over the past year for which he has undergone extensive work-up recently.As of today, the devices, all of which were used in treatment, remain implanted and therefore cannot be tested.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 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.Based on the limited information provided, the clinical root cause of the reported elevated metal ion levels and systemic symptoms cannot be determined.However, the implantation operative report notes the acetabular component was impacted at 25 degrees of anteversion and per the surgical technique, the position should be 15-20 degrees of anteversion.It is unknown to what extent the position of the acetabular component had on the patient¿s clinical status.It cannot be concluded that the reported events are associated with a malperformance of the implant.The patient impact beyond that which has already been reported cannot 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.Additional information: h4, d9, e2.Corrected data: d10, h6 (health effect - impact code).
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