Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2010 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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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Pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pseudotumor.During the revision operation the first liner they used wouldn't seat on the head, it was believed to be caused by soft tissue.A new liner was opened and it seated correctly.The complaint was updated on: 01/23/2015.Doi: (b)(6) 2008.Dor: (b)(6) 2010, (right hip).
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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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