Model Number 1506-00-007 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Not Applicable (3189); No Code Available (3191)
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Event Date 05/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 was revised to address loosening of the tibia at the cement to implant interface.Depuy cement was used.Doi: (b)(6) 2015; dor: (b)(6) 2018; 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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Event description from the duplicate (b)(4):the patient underwent a right knee revision due to pain, adhesions, and tibial tray loosening at an unknown interface.The surgeon noted the anterior flange of the femoral component was slightly off of the anterior femur which allowed good access to disrupt the cement mantle.Depuy cement was used during the primary operation.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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. added:b5,h6(patient codes),h6 patient code: no code available (3191) used to capture medical device removal.Corrected:a1,b4.These information have been reported in (b)(4) with an mfr number 1818910-2019-103217.Mfr number 1818910-2019-103217 has been retracted due to a duplicate of this mfr number 1818910-2018-62276.Additional information will be added in this complaint moving forward.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: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: b1.
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Search Alerts/Recalls
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