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Model Number 5450-32-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Discomfort (2330); Fibrosis (3167); No Code Available (3191)
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Event Date 12/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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On (b)(6) 2018, the patient underwent a third right knee revision due to pain, arthrofibrosis, discomfort, decreased range of motion, scarring, and tibial loosening at the cement to implant interface.The surgeon noted a tibial stress fracture while removing the tibial tray.The fracture was corrected with a screw and cement.Two depuy cement were used during the first revision on (b)(6) 2016.Doi: (b)(6) 2016 (2 depuy cements); (b)(6) 2018; dor: (b)(6) 2018.Right knee.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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: 7957560.Device history batch: null.Device history review: a device history record (dhr) review on legacy complaint (b)(4) found no non-conformances on this batch.Final micro and sterility tests passed.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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Search Alerts/Recalls
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