(b)(4).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.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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On (b)(6) 2003, the patient underwent a primary right total ankle replacement.Depuy products were implanted along with two unknown manufacturer screws.The surgeon indicated an intra-operative complication of nicking one of the veins in the neurovascular bundle, the nick was cauterized and then tied off with no indicated resulting patient, injury, harm, or resulting complication.The event occurred prior to the use of any depuy product.On (b)(6) 2019, the patient underwent a right ankle removal of total ankle components and placement of competitor nails and fusion of adjacent bones.All depuy products were removed.Prior to the procedure, the patient was experiencing the following adverse symptoms: pain, decreased range of motion, edema, difficulty walking, osteolysis, numbness, weakness, instability, cysts, stiffness, and loosening of the entire system.The surgeon also indicated removing two stripped screws (of unknown manufacturer).
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since (b)(6) 2015.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h5.
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