Model Number 25004011E |
Device Problems
Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); Swelling (2091)
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Event Date 02/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device history record indicated that the released components met all specifications.The complaint history review indicated no trends among components by failure modes.Should additional information be obtained to further this investigation, the report will be updated.
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Event Description
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The patient presented with a lump on their knee, which was suspected to be caused by an infection.A revision surgery was performed to drain and irrigate the knee.Upon removing the poly components, the surgeon observed that the cemented stem was loose.The surgeon washed the femoral intramedullary canal and placed new components without cement.
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Manufacturer Narrative
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This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa 18-007.As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdrs were filed when required.The results of this retrospective assessment prompted onkos surgical to file this report.This report is for one of six devices involved in the event, please refer to report 3013450937-2018-00058, 3013450937-2018-00059, 3013450937-2018-00060, 3013450937-2018-00061, and 3013450937-2018-00062 for the others.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and explanted components were requested, but it was relayed that they were unable to be obtained.From the available information it was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained the report will be supplemented.
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Event Description
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The patient presented with a lump on their knee, which was suspected to be caused by an infection.A revision surgery was performed to drain and irrigate the knee.Upon removing the poly components, the surgeon observed that the cemented stem was loose.The surgeon washed the femoral intramedullary canal and placed new components without cement.
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Search Alerts/Recalls
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