H3, h6: the study of garcía-rey e.[1] reports surgeries on 889 hips.In 330 cases a sl stem was implanted in combination with an ep-fit cup.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported, that in one case the patient suffered from an aseptic loosening 42 months after implantation.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.The reported failure mode might occur in some cases, which is stated as a side effect in the instructions for use lit.No.12.23 ed.05/16.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.[1]: garcía-rey e.The fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years.Hip int.2020 jan 7:1120700019895983.Doi: 10.1177/1120700019895983.Epub ahead of print.Pmid: 31908180.
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