Us legal: bilateral patient.It was reported that, after a right bhr on (b)(6) 2010 plaintiff has experienced metallosis and mri suggested a possible right iliopsoas bursitis.No revision surgery has been performed, only conservative measures.Revision surgery on left hip was performed on (b)(6) 2016.The plaintiff's outcome is unknown.
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H3, h6.It was reported that, after a right bhr on (b)(6) 2010 patient has experienced metallosis and mri suggested a possible right iliopsoas bursitis.No revision surgery has been performed, only conservative measures.As of today, the implanted devices, which were all used in treatment, remain implanted in the patient and therefore cannot be evaluated.A review of the historical complaints data for the acetabular cup and femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and for the part number and the reported failure mode for both devices, 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.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.No further escalation actions required.The available medical documents were reviewed.It should be noted no revision, nor metallosis for the right hip was noted in the provided documents.With the information provided the clinical root cause of the neck thinning cannot be confirmed; however, the patient¿s overweight body habitus cannot be ruled out as a contributing factor.The patient impact beyond the neck thinning cannot be determined.Based on the information provided we cannot confirm or further investigate the reported complaint, 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.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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