Patient suffered and/or will suffer pain, inhibition of the ability to walk, unnecessary and additional surgery, and other injuries presently undiagnosed.Update 12/7/15 medical records received.Medical records reviewed for mdr reportability.The revision surgical report dated (b)(6) 2015, noted that the patient hip made noises, patient had increasing serum cobalt and chromium levels, significant debris in the fluid, joint effusion, crepitation with flexion and internal rotation, impingement anterior neck, minimal metallosis, oxidation of the trunion and osteolysis.Unknown stem and sleeve added for the oxidation, hight metal ions, and impingement.
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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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
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