Device used for treatment, not diagnosis.Additional narrative: patient age and weight not provided for reporting.(b)(4).Per additional information the explant date may be: (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4).Manufacturing date: 05-jul-2012.Expiration date: 31-may-2017.Part #: 09.402.024s, lot#: 6892441 (sterile) - 24mm cocr radial head standard height/13.0mm - sterile.Quantity 38.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3/h6: article: 04.402.008/7013303 radial stem, uncemented, straight, size 8mm, l 28mm.09.402.024s/7529642 radial head 0 24mm, incemented, standard height 13.0mm.Cause of investigation: loosening of the radial head prosthesis - removal surgery needed.Cause of failure: the investigation has confirmed that these implants are subjected to delivery stop ds2016615 and ds2016620 and the parts are consequently blocked in the sap system.In addition on (b)(4) 2016 synthes (b)(4)has initiated a voluntary medical device removal (recall) of the depuy synthes radial head prosthesis system due to the possibility that the radial stem may loose post-operatively at the stem bone interface (fsn 555531).This report has been registered in our market vigilance system and the corresponding statistical data will be kept under trending.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|