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It was reported that right hip revision surgery was performed.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 devices concerned 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 hemi head and sleeve.As these devices are no longer sold, no action is to be taken.Similar complaints have been identified for the acetabular cup.This 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.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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible for the hemi head and sleeve.No prior applicable escalation actions were identified for the acetabular cup.No further escalation actions required.The available medical documents were reviewed.Evaluation revealed elevated metal ion levels.Mri failed to reveal any large pseudotumor.The ¿systemic symptoms¿ were not given nor were lab values or lab reports provided.Revision intraoperative report noted, clear yellow fluid, no large pseudotumor present, significant trunnion corrosion; however, there was no macroscopic damage to the trunnion itself.There was no evidence of deep infection.It should be noted, the birmingham hip surgical technique indicates ¿sequential reaming with hemispherical acetabular reamers is then performed and in normal consistency bone, reaming proceeds to 2mm less than the definitive acetabular component to be inserted.¿ the under-reaming and noted ¿small area of superior uncoverage because of the acetabular morphology¿ cannot be ruled out as possible contributing factors to the reported clinical reactions/events.It cannot be concluded the reported clinical reactions/events were associated with a mal performance of the implant or implant failure.With the information provided, the patient impact beyond the reported clinical reactions/events cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and 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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