Country of complaint: (b)(6).Revision due to low-grade-infect.Implant could be explanted with 2 to 3 punches.Hardly cement compound.All med watch submissions related to this report are: 9610612-2018-00025, 9610612-2018-00026.Components in use listed as concomitant devices are: no188z / as univation xf femur cemented f4 lm, no166z / as univation xf tibia cemented t, nl480 / univation f meniscal comp.T5 rm.
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Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.No abnormalities or damages were found on the coated surface of the implant.On the femur, as well as on the tibia component, some bone cement residues could be found.Batch history review: the device quality and manufacturing history records have been checked and found to be according to our specification, valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available as well as a result of our investigation we assume that the root cause of this failure is not product related.Rational: it could be possible that there were problems with the cement technique.Potential sources of faults relating to the cement.The processing time of the used cement was exceeded.Incorrect temperature, unfavorable storage, the age of the cement, incorrect handling of the cement.No capa is necessary.
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