Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Naturally Worn (2988)
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Patient Problems
Fever (1858); Pain (1994); Sepsis (2067); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 03/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.
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Event Description
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Asr claim letter received alleging pain, wear increased blood metal ion levels, fever, septicemia and injury.Doi: (b)(6) 2009 - dor: (b)(6) 2016 (right hip).
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Search Alerts/Recalls
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