Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Ppf alleges dislocation with closed reduction, metal wear, metallosis and elevated metal ions confirmed in medical records.Unf has no allegation provided.After review of the medical records the patient was revised to address instability with metallosis, large pseudotumor with destruction of the gluteus medius, gluteus meniscus, piriformis, vastus lateralis, osteolysis of the greater trochanter, elevated metal ions, metal wear, leg length discrepancy, loss range of motion, pulmonary embolism, neurovascular damage and pain.Operative note reported fascia was thinned and a large amount of fluid was obtain in the greater trochanter, there was pseudotumor due to metallosis, ostial lysis of the greater trochanter, necrotic tissue and bone, disrupted vastus lateralis and muscle loss.The greater trochanter was completely devoid of all tendinous attachment.Pseudutomor, necrotic tissue, bone and metal wire were all removed.There was osteolysis specifically around the acetabulum.Doi: (b)(6) 2007.Dor: (b)(6) 2020.Right hip.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H6 clinical codes: appropriate term / code not available (e2402) is used to capture blood heavy metal increased.Necrosis (e2327) is used to capture necrosis and soft tissue necrosis.E3 initial reporter occupation: lawyer.
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