Model Number 5450-31-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Distress (2329); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)
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Event Date 02/04/2019 |
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.Initial reporter occupation: lawyer.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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Attune knee claim record received.Claim record alleges personal injuries, pain, anguish, disfigurement, physical impairment and loosening of the tibial component at the cement to implant interface.Depuy cement was used.All of the depuy attune knee and bone cement products were removed and replaced with competitor products.On (b)(6) 2015, the patient had a right total knee arthroplasty to address right degenerative joint disease with varus deformity.Depuy components including depuy patella depuy cement x2 were used during this procedure.(sticker page 8 of 13).On (b)(6) 2019, the patient was revised to address failed right total knee arthroplasty.The indications for surgery included pain and limited motion.Loosening of the tibial tray was noted at the cement/implant interface.The femoral component was noted to be well fixed, but still revised.Doi: (b)(6) 2015, dor: (b)(6) 2019, right 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.
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Search Alerts/Recalls
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