Model Number 5450-31-500 |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
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Event Date 10/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Dmf#: (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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Clinical notification received for revision of right total knee to address infection.Date of implantation: (b)(6) 2018, date of revision #1: (b)(6) 2020, date of revision #2: (b)(6) 2021, (right knee).Treatment: all products explanted and antibiotic spacer placed.
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Event Description
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The patient underwent a right knee revision to address infection, pain, swelling, synovitis, removal of fibrous tissue, and tibial component loosening.The surgeon had to perform a coronal plane osteotomy of the distal femur to remove the well-fixed femoral components.There was noted to be removal of cerclage wires on the femur that were placed prior for an unknown reason on an unknown date.It is unknown if the wires were previously placed due to a complication or to prevent any issues.
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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 : 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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