Model Number 1506-00-004 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Joint Laxity (4526)
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Event Date 11/16/2020 |
Event Type
Injury
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Event Description
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Medical records received ad (b)(6) 2020.On (b)(6) 2016, the patient underwent a left total knee arthroplasty due to osteoarthritis of the left knee.Depuy components and depuy cement x2 were used during this procedure.Doi: (b)(6) 2016; dor: (b)(6) 2020; (left knee).
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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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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