Model Number 1294-33-160 |
Device Problems
Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Distress (2329); Discomfort (2330); Injury (2348); Joint Disorder (2373); No Code Available (3191)
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Event Date 08/29/2017 |
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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Patient initiated form received.It was reported that the patient was revised due to so much pain and suffering.Doi: (b)(6) 2012: dor: (b)(6) 2017 (left 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.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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Revision for loosening of the femoral and tibial components, pain, and swelling.
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Manufacturer Narrative
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(b)(4).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.(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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Manufacturer Narrative
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(b)(4).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.
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Event Description
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Litigation record received.Litigation alleges pain, injury, swelling, stiffness, weakness, discomfort, emotional distress and effusion in the left knee with documented infection.It was also confirmed that the indication for surgery was "the left tkr with aseptic loosening of the femoral and tibial components.".
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: update 5-nov-2020: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.
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Search Alerts/Recalls
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