Catalog Number 999800312 |
Device Problems
Corroded (1131); Degraded (1153)
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Patient Problems
Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Test Result (2695)
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Event Date 09/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.
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Event Description
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Patient was revised due to increasing cobalt-chromium levels and pain.Revision note reported some necrosis to the anterior capsule, pseudotumor extending into the ilopsas masculature, and taper corrosion.Doi: (b)(6) 2008 - dor: (b)(6) 2018; (left 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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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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Search Alerts/Recalls
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