Model Number 62-3411L |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/11/2022 |
Event Type
Injury
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Event Description
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Revision surgery: (b)(6) 2009 patient (r) side revision of competitor products (unknown implants revised).Revision surgery: (b)(6)2010 patient (l) side revision of competitor products (unknown implants revised).Revision surgery: (b)(6) 2022 patient (l) revision of depuy products: femoral component loose and needed revision.Implants insitu (affected items listed following under 8.3.2010 - refer to source data).Femoral components removed and revised to larger stem and sleeve.Existing plateau re used.Tibia remains insitu.
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Manufacturer Narrative
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Product complaint # (b)(4).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.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received indicated that there was no surgical delay reported.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.All available x-ray evidence were reviewed and cannot be establish the loosening condition reported.Based on the information, a defect or malfunction cannot be determined which could be attributed to the reported event, therefore the allegation is not confirmed.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.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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