On the literature article named "ceramic-on-ceramic vs ceramic-on-polyethylene, a comparative study with 10-year follow-up", it was reported that after a ep-fit plus family shell had been implanted on 5 patients, after a 10 year follow up, atrophy around the cup was found in delee and charnley zone 1 in 5 patients from the coc group.It was not reported if/how the adverse event was treated.
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(b)(6).As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported, that on 5 patients, after a 10 year follow up, atrophy around the cup was found.It was not reported if/how the adverse event was treated.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu lit.(b)(6).The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode and the relationship between the device and the reported event cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.(b)(6).
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