Model Number 62-3401L |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 07/20/2020 |
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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The patient was revised to addressed loosening of the femoral component at cement to implant interface.It was also reported that the patient is having pain and discomfort in the knee surgeon notice that the femur may have been loose.So he removed hinge with sleeve, stem and poly and replaced with a new hinge, cemented stem and poly.I don¿t know when or where it was previously implanted and couldn¿t locate some of the lot numbers on the implants.Doi: (b)(6) 2013.Dor: (b)(6) 2020.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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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