Catalog Number UNKN1102901 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Failure of Implant (1924); Joint Laxity (4526)
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Event Date 04/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.
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Event Description
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It was reported that on literature review ¿hip international - 2013 - the fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years¿.It was reported that the sl-plus stem was revised due to aseptic loosening 78 months after implantation.Primary surgery was performed due to onfh.
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Manufacturer Narrative
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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 78 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.A complaint history review was performed.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu 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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Search Alerts/Recalls
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