Model Number 1504-10-123 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/28/2021 |
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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The patient's knee was revised to address loosening of the femoral and tibial component at the cement to implant interface.Depuy cement was used.Doi: (b)(6) 2016, dor: (b)(6) 2021, left knee.
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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 at this time.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).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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