Device evaluation per the exponent report: "the articulating surface of the polyethylene insert showed machining marks and multidirectional scratches consistent with minimal wear.Cutout deformation on polyethylene insert was observed.Overall the results of the stage i analysis are consistent with a device having impingement and a short implantation time." based on what can be seen on the device, the failure of removed due to persistent post-op pain cannot be confirmed.The complaint is unrefuted.Potential cause root cause was unable to be determined.This event could possibly be attributed to unknown patient, operational or traumatic factors.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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