Patient age, date of birth and weight is not provided for reporting.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record review was performed on part 04.402.007s, lot # 7846006: release to warehouse date: 17-mar-2015, expiration date: 02/2020, supplier: (b)(4).No non conformance reports (ncrs) were generated during production; review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.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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It was reported that a patient was initially implanted with the radial head prosthesis system on (b)(6) 2015.The patient was brought back to the operating room three days later on (b)(6) 2015 for a revision of the initial implants due to instability.It was reported that the joint was overstuffed and therefore, the surgeon put in smaller devices and also performed an ulna ligament repair.No additional information is available regarding this surgery.Patient underwent a total of five surgeries.This report addresses the first revision surgery held on (b)(6) 2015 due to instability.The surgery, which took place on (b)(6) 2015 to place an external fixator, has been captured under linked (b)(4) also the hardware removal which took place on (b)(6) 2016 as implants remained loose has been captured under linked (b)(4).This report is for one (1) 7 mm ti straight radial stem 26 mm-sterile.This is report 2 of 2 for (b)(4).
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