The tha surgery was performed on the patient¿s left hip joint by using the pinnacle cup (p/n: unknown), the s-rom stem (p/n: unknown) when the patient was (b)(6) (date of surgery was unknown).It was reported that postoperative atrial fibrillation occurred when the patient was (b)(6), and long-term anticoagulation therapy with warfarin (1.5 mg/day) was started.It was a report from this clinical study, not customer complaint.
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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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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.H10 additional narrative: product complaint (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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