Catalog Number 121720500 |
Device Problems
Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
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Patient Problem
Osteolysis (2377)
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Event Date 01/28/2013 |
Event Type
Injury
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Event Description
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Pfs with primary and revision medical records received.The patient was revised because of loose cup, metallosis, and osteolysis.
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Manufacturer Narrative
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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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The devices associated with this report were not returned.A review of the device history records for the (b)(4) lot code did not reveal any related manufacturing deviations or anomalies.A complaint database search for the (b)(4) lot code found one manufacturing deviation.It was confirmed that the deviation should have had no effect on the reported complaint.A complaint database search finds no other reported incidents against the remaining product and lot combinations.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.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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Manufacturer Narrative
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Product complaint # = > (b)(4).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. additional narrative: added: (age).
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Event Description
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Update ad 10 jul 2018.(b)(4) was re-opened under (b)(4) due to receipt of ppf and sticker sheet.In addition to what was previously alleged, ppf alleges metal wear and elevated metal ions.Stem was added to the complaint due to alleged elevated metal ions.Added law firm, revision hospital, surgeon and patient age.
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Search Alerts/Recalls
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