Model Number 5450-32-500 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Edema (1820); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
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Event Date 01/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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The patient presented for post-primary evaluations of the left knee on (b)(6) 2018 and (b)(6) 2018.The patient complained of pain, "snapping, cracking, and popping" of the knee, swelling, and stiffness.X-ray images showed the components to be intact, aligned, and with no fractures.The physician indicated he suspected tibial tray loosening.There is no evidence of revision or intervention.Three depuy cement products were used during the primary operation.Doi: (b)(6) 2016.Doe: (b)(6) 2018.Left knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: update 24-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Visual examination of the provided photographs confirmed the reported event.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot: device history reviewed on (date) 1 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 31 mar 19.There were no anomalies identified on this lot.Dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, and strength ¿ 1.0g active in our cements.
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Search Alerts/Recalls
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