Model Number 1506-10-004 |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problems
Pain (1994); Not Applicable (3189)
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Event Date 07/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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Reviewed medical records on 11 may 2018.Left knee revised for pain, medial tibial collapse and aseptic tibial base plate loosening at the cement to implant interface.Femoral and tibial components were revised.Revising surgeon indicated that femur component was well-fixed, but the tibial base plate was completely loose, debonded entirely from the cement mantle.The cement mantle itself was well fixed to the bone, requiring segmental removal.There was a significant medial tibial bone defect from the medial collapse of the tibial prosthesis.All tissues sent for pathology demonstrated no evidence of acute infection.Indicated patella was intact and tracked well, and so was 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.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: h6 (device).
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Search Alerts/Recalls
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