Model Number 5450-50-501 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4),trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.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 address loosening of the femoral component at the cement to implant interface.Two depuy cements were 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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: as part of previous investigation (b)(4) a device history record (dhr) review was conducted and did not reveal any related manufacturing deviations, anomalies or any other non-conformances on the provided product and lot combination.Final micro and sterility tests passed.
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Search Alerts/Recalls
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