New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - litigation alleged the patient suffered severe metal poisoning and metallosis, metal debris within the joint space, pain and other permanent injuries as a result of the implanted asr hip.Update 4/18/16 medical records received.Medical records reviewed for mdr reportability.Primary surgical report noted patient lost 700ml of blood during procedure.Revision surgical report noted patient had chronic pain, a bit of an effusion with evidence of metallosis, soft tissue reaction to metal, taper noted to have corrosion, stem with corrosion, evidence of impingement anteriorly on femoral stem, some evidence of wear on cup and a cyst on the anterior wall of the acetabulum.Taper sleeve and stem added to complaint for corrosion 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.(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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