Der states the surgery was scheduled as a head/liner exchange for failed tha.The x-rays showed the possibility of liner wear.When the hip joint was exposed, it was evident that the liner had broken & the ceramic head was articulating with the cup.The head, liner, and cup were removed.The joint tissue was debrided.New 56mm gription sector, 2 screws, hole eliminator, altrx liner, and ts ceramic head were implanted.Liner was loose.Cup was well fixed.Doi: (b)(6) 2013; dor: (b)(6) 2017; right hip.
|
(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|