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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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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Device report from synthes reports an event in japan as follows: it was reported that the patient underwent open reduction/internal fixation of the femur with the pfna in 2007.On (b)(6) 2022, the patient felt pain in the pelvis and visited the hospital.It was found that there was a fracture in the pelvis, and the pfna was fractured.Additionally, pseudoarthrosis had occurred.There was no pain due to the pfna breakage.The surgeon decided to remove the pfna and perform pelvis reduction and total hip arthroplasty.Reoperation was done on (b)(6) 2022.The removal surgery was completed successfully with no delay.According to the surgeon, the lower right side of the body had poor mobility, and the bone quality was not good.The patient status was reported to be stable.This report involves one unk - nails: pfna.This is report 1 of 1 for (b)(4).
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