Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 05/31/2013 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.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.Occupation is a non-healthcare professional.(b)(4).
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Event Description
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Litigation alleges injury, exposure to elevated levels of metal toxin, pain, and suffering which has greatly impacted the patient's quality of life.Doi: (b)(6) 2005; dor: (b)(6) 2013; unknown hip.
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Search Alerts/Recalls
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