Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Test Result (2695); No Code Available (3191)
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Event Date 03/30/2010 |
Event Type
Injury
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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.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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Event Description
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Ppf and sticker sheets received.Ppf alleges elevated metal ions before first revision.Doi: (b)(6) 2004 - dor: (b)(6) 2010 (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).(b)(4) used to capture blood heavy metal increased, medical device removal and surgical intervention.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).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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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