Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Liner breakage post-op.More than 9 months after bilateral hip arthroplasty, the patient had left hip movement sound.The patient went to the hospital for examination, and it was found by x-ray that the ceramic liner implanted on the left side was cracked.A second surgery was required, but the timing of the second surgery is currently uncertain.
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