Model Number 130760000 |
Device Problems
Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 07/08/2020 |
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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Patient was revised due to loosening of the glenosphere at the bone to implant interface.Patient had an accident in nursing home in 2018 that contributed to loosening of the glenosphere.The loose hardware was removed.The cemented delta stem was well fixed.Surgeon implanted cta head on stem.Doi: (b)(6) 2011, dor: (b)(6) 2020, left shoulder.
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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.¿ added: b5 and h6 (device).Corrected: h6 (patient).
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Event Description
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The metaglene was completely loose and dislodged from the glenoid and the glenosphere was detached from the metaglene.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary- the device associated with this report was not received for examination.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.
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Search Alerts/Recalls
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