[2634705]
On (b)(6) 2012, a spontaneous report was received from a physician involving bio-gide membrane. Additional information was received on (b)(6) 2012. This involved a (b)(6) female with a medical history of right knee pain secondary to right knee cartilage "wearing away"; also reported as an osteochondral defect. Concomitant medications and known drug allergies were not reported. In (b)(6) 2011, the patient underwent cartilage cell implantation with bio-gide used as a scaffold (meddra coded off label use). The physician reported that immediately post operatively, the patient experienced a swollen right knee with effusion (meddra coded joint swelling and joint effusion). As of (b)(6), the physician reported the patient had not been treated with antibiotics nor additional surgical treatments. In (b)(6), 2012, an mri revealed the patient had developed right knee inflammation (meddra coded arthritis) and right patellar degradation (meddra coded bone disorder). (b)(6) 2012 lab results included an elevated ige of 183 (high normal reported as 114) (meddra coded blood immunoglobulin e increased). The patient was scheduled for consultations with an allergist and a rheumatologist the week of (b)(6) 2012. On (b)(6) the physician considered the right knee inflammation most likely due to bio-gide. On (b)(6), the physician reported the patient continued to experience recurrent effusions and the bone graft fell apart (details not provided). Bovine and porcine were not positive on allergy testing and the physician did not feel the events were related to bio-gide. On (b)(6) 2012, additional information was received from the physician, a surgeon, who confirmed that the bio-gide membrane was used to contain the patient's own chondrocyte cells used for implantation as treatment for an osteochondral defect in the medial femoral condyle. The patient did complete the post operative physical therapy that was prescribed. The patient continued to have swelling in the knee. A rheumatoid work up was negative for allergies. Two aspirations from the knee were negative for infection. On (b)(6) 2012, the patient underwent "reconstruction surgery" using autologous tissue referred to as a "sandwich procedure". The surgeon described this as a procedure in which the patient's periosteum was used as a patch. During the second procedure he found sclerotic bone. Biopsies were obtained and sent out and pathology results were pending. The physician felt that a vitamin d deficiency was contributing to the patient's reactions and stated again that he did not feel the reactions were caused by the bio-gide membrane. Patient outcome was not reported.
Patient Sequence No: 1, Text Type: D, B5