Model Number 1024-51-200 |
Device Problems
Loss of or Failure to Bond (1068); Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/07/2021 |
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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Revision of a depuy sigma uni knee replacement.Reason for revision was due to medial collapse/loosening of implants.All implants were removed and an attune total knee was implanted.Implants not available for return.
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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.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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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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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 was received stated that the tibial component was loose and had subsided.Cmw2 would have been used.There was no any adverse consequences that affected the patient because of implant migration and we were able to implant a primary knee replacement as there wasn¿t any significant bone loss.
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Search Alerts/Recalls
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