Patient underwent revision surgery on unknown date.Implanted (b)(6) 2009 following femoral neck fracture.Prosthesis misalignment was diagnosed on the basis of poor hip abductor strength, a large prosthetic head (40 mm), and a cup inclination angle of 64(ideally 40¿50 to optimize wear rates).
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It was reported that hip revision surgery was performed on unknown date.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but has not become available.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a r3 liner in search of complaints involving elevated tests results throughout the lifetime of the product.Similar complaints have been identified and this failure will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No clinical/medical documents are available for review.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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