Catalog Number 121725500 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)
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Patient Problems
Host-Tissue Reaction (1297); No Information (3190)
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Event Date 04/30/2013 |
Event Type
Injury
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Event Description
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Patient was revised to address cup loosening.Update rec'd (b)(6) 2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from inflammation, pain, discomfort, gray discoloration of her inner synovium, toxic cobalt and chromium metal ions and particles to be released into the blood, tissue and bone and difficulty ambulating.Update rec'd (b)(6) 2014- pfs and medical records received.Part/lot was provided.After review of the medical records the revision operative note confirmed a loose cup.The note also indicated the 2 screws were stable in the bone, but loose at the screw/acetabular shell interface.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 8/18/2014.
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Manufacturer Narrative
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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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Additional narrative: examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Udi: (b)(4).
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Event Description
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Ppf alleges metallosis.
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Manufacturer Narrative
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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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Search Alerts/Recalls
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