(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3005751028 - 2020 - 00058.Concomitant medical product(s): unk liner; unk stem; stryker restoration cup 56 mm part#1235-2-562 lot#g5830067; stryker x3 size 28/56 insert part#1236-2-856 lot#306413; cer option type 1 tpr sleve +6 pe 1 part#650-1068 lot#646880; delta ceramic option head dia2 8 part#650-1055 lot#195030.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.3rd revision op notes dated (b)(6) 2016 demonstrated that the patient was revised due to cup loosening.Same bone loss was identified around femur and acetabulum as what was identified in the previous surgery.Acetabular augment had lost it fixation to the bone and spontaneously de-coupled from the acetabular component.Acetabular component was moving slightly but was not grossly loose.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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