Literature article entitled: "outcomes of a metal-on-metal total hip replacement system" by gs matharu, k theivendran, pb pynsent, l jeys, am pearson, dj dunlop published in ann r coll surg engl 2014; 96: 530¿535, was reviewed for mdr reportability.The study analyzed the outcomes of metal on metal thr systems involving the corail stem, pinnacle cup, ultramet liner, and articuleze femoral head.578 uncemented hips were followed in the study.39 hips from 38 patients were revised within a mean time of 3.5 years.They were identified by age/gender.Patient #35 is a 69 year old female revised for adverse reaction to metal debris.Elevated cocr blood metal ions were noted prior to revision.The head and liner were revised.Intraoperative findings included effusion, 20ml of black stained metal debris fluid and the trunnion was stained black.No further details given on the black staining which makes it inconclusive.
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|