Asr claim letter and medical records received.Claim letter alleges pain, dizziness, nausea, weakness, fainting, fatigue, discomfort, depression, post-traumatic stress disorder, prostatic adenocarcinoma these signs and symptoms and diagnosis were due to metal poisoning, heavy metals cobalt and chromium in the body.Lab reports above 7 ppb.Claimant is seeking for damages.After review of medical records the patient was revised due to mechanical complication of internal joint prosthesis resulting to metallosis, elevated metal ions, vertigo and limping.Doi: (b)(6) 2008.Dor: (b)(6) 2017 ; left hip.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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- 001226.Ongoing post market surveillance is conducted per our procedures for this product.Device history lot : null.Device history batch : null.Device history review : null.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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