Model Number 1506-10-003 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Pain (1994)
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Event Date 05/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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 attune rp tibial base plate due to loosening.
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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 was received indicated that the cement implant interface was loose.The cement that was used would have been palacos, not depuy.
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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, and review of the photograph could not confirm the reported loosening.Depuy synthes considers the investigation closed at this time.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).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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