Asr claim letter alleges coxalgia, difficulty in walking, headache, defective vision, photosensibilization, physical and psychological sufferings.It was also stated that explorative surgery reported of metal poisoning, pain, spilling body fluid, scar tissue, chronic inflammation, amorphous and necrotic material with histiocytes.Laboratory results for cobalt and chromium ions were above 7(no unit provided).Doi: (b)(6) 2009- dor: not revised(right hip).Patient underwent explorative surgery on (b)(6) 2012.
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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.
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