Model Number 1506-00-004 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Not Applicable (3189); No Code Available (3191)
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Event Date 02/12/2018 |
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 received on 11 may 2018.Right knee revised to address increasing pain, with evidence of tibial base plate lucency per radiographs.Revising surgeon indicated tibial component was very loose, coming out with a light touch of the mallet.Surgeon also indicated that the competitor bone cement mantle was loose at the tibia bone to cement interface.Patella and femur components were well-fixed.All implants were explanted and a competitor knee implanted.
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Manufacturer Narrative
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Product complaint # = > pc-(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 synthes 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: added: b1 and h6 (patient code).H6 patient code: no code available (3191) used to capture the surgical intervention.
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Search Alerts/Recalls
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