Model Number 1506-00-006 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Pain (1994)
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Event Date 11/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Patient was revised for implant loosening and pain.Explanted the attune femoral and attune fixed bearing tibial component.There was no cement under the tibial tray.Cement interface was with bone.Femur had cement in the distal area but not under the anterior flange and posterior condyles.Implanted attune rev rp tibia with sleeve and pressfit stem.Implanted an attune crs femur with sleeve, augments and pressfit stem.Patella was still intact and not revised.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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