Model Number 130760138 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)
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Event Date 09/01/2020 |
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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Reason for revision: aseptic loosening leading to dislocation, pain & osteolysis.The reason for revision is dislocation.The cause of the dislocation is uncertain.She is demented, and there is an x-ray documenting a reduced joint three weeks ago.The joint has been painful.Humeral component may be loose.Patient will be revised to a cemented humeral component, though stability may still be an issue.Attended revision case.Primary pe cup and humeral stem were worn and explanted.Surgeon noted 'tarnishing" to the glenosphere, but opted to leave it in-situ due to patient frailty despite advice to exchange it.Cemented delta xtend (long stem) used with new pe cup during revision to restore function.Surgeon believes that osseo-integration of the primary humeral stem never full occured so stem became loose and mal-rotated causing implant impingement & metal on metal contact/wear leading to further aseptic loosening and subsequent osteolysis and dislocation.Action taken :the patient required a revision to a cemented delta xtend long stem with new pe cup.Patient condition: dementia.Female patient initials: m.M height 180cm weight (b)(6).
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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.H10 additional narrative: corrected: d3, d6, g1.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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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.Patient code: removed code for absence of treatment and replaced with no code available (3191) to capture surgical intervention.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : 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.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.Device history lot : the dhr analysis of the batches indicated shows an initial conformance of these products with regards to their specification.For these batches, there was no deviation or non-conformance.
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Search Alerts/Recalls
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