Catalog Number 999804047 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Tissue Damage (2104); Not Applicable (3189); No Code Available (3191)
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Event Date 03/15/2018 |
Event Type
Injury
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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.No 510(k) number provided because this implant product code was sold internationally.It was sold in the us under a different product code.The correction/removal reporting number listed applies to the corresponding product code sold domestically.
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Event Description
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Asr revision; asr hip resurfacing system.Reason(s) for revision: pain, alval/ soft tissue reaction, raised cobalt and chromium level.Doi: (b)(6) 2009; dor: (b)(6) 2018; unknown affected side.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > 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.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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