The associated complaint devices were not returned.A clinical evaluation was conducted the root cause of the dislocation is the crossing of the legs which is contraindicated post op hip surgery.The impact on the patient beyond revision surgery is undetermined.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc).It was reported that a revision was performed due to dislocation of hip approximately one month post hip surgery implantation after crossing legs.Crossing legs post hip surgery is contraindicated in the healing process.An x-ray has been submitted and does not show a reason for the dislocation and its presumed that it¿s for the left side as that¿s the side that has the reported tandem bipolar head.However, there is no further other supporting documentation to include in this clinical assessment.In conclusion: the root cause of the dislocation is the crossing of the legs which is contraindicated post op hip surgery.The impact on the patient beyond revision surgery is undetermined.In conclusion: the root cause of the dislocation is the crossing of the legs which is contraindicated post op hip surgery.The impact on the patient beyond revision surgery is undetermined.
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