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H3, h6: it was reported that a left hip revision surgery was planned for a patient due to pain, failed total hip and elevated metal ion levels.However, it is unknown if the surgery was actually performed.As of today, if the implanted devices were revised, these have not been returned for evaluation and might still remain implanted 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.No other similar complaints have been identified for the cup, the hemi head and the sleeve regarding a search per their batch and a search per product numbers during the last 12 months.However, this failure will continue to be monitored for the cup.This will continue to be monitored via routine trending for the hemi head and the sleeve, however it should be noted that this device is no longer sold.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 for the cup.Following the review, prior applicable escalation actions were identified for the hemi head and the sleeve and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.A clinical root cause could not be determined.The patients bmi 43.26, and multiple falls cannot be ruled out as possible contributing factors to the reported pain.A clinical root cause for the elevated cobalt cannot be definitively confirmed.The patient impact is determined to be the reported pain, elevated cobalt and recommended revision.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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It was reported that the patient reported right hip pain, and several falls 4 years after the implantation of a left bhr in 2010.The patient was scheduled for a left hip revision surgery due to failed total hip, however, it is unknown if the surgery was actually performed.Also, test results performed 6 years after the primary surgery revealed elevated metal ion levels.No further information is available.
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