(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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The surgery via tha or bha or the joint conservative surgery was performed for onfh with crushing.Great surgical results were reported, but long-term survival and postoperative complication are concerned.The object of this study was to report a case which both sides disassembly of bipolar heads (p/n: unknown) occurred within a decade of a primary surgery via bha for onfh.The patient was (b)(6) years, male, a carpenter.When he was (b)(6) years, he underwent the primary surgery via bha for his both sides hip joint for onfh.After the primary surgery, he had a pain for his right hip joint on job.By x-ray, the disassembly of the right bipolar head inside of the joint (exterior and interior of the bone head) was confirmed.The first revision surgery was performed via tha for his right hip joint.5 years after, he had a pain for his left hip joint.By x-ray, the disassembly of the left bipolar head which was similar to right hip joint was confirmed.The second revision surgery was performed via tha for his left hip joint.When both revision surgery, on both sides of hip joint, the surgeon found that the polyethylene bearings were wear and peeling notably and failure of the locking mechanism between 22mm inner head with skirt and polyethylene insert.And, degeneration of both hip acetabuli was confirmed.The disassembly of the bipolar head was caused by failure of self-centering mechanism due to degeneration of acetabuli, impingement between outer head and neck, and the patient¿s high activity.From the above, patient¿s age, activity and work were important element to consider in determining type of artificial joint.It was a report from this clinical study, not customer complaint.
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