The reason for this revision surgery was a result of a lima hip stem that was not aligned properly in the patient's hip and loosening.The in-vivo service duration for this product was 4.9 months.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with this product.A review of the product complaint report history showed this is the first complaint against this part and lot number.The root cause of this event could not be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.
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