(b)(4).No device or photos were received; therefore the condition of the device is unknown.The device history records were reviewed and no discrepancies relevant to the reported event were found.A review of the complaint history determined that no further action is required as no trends were identified.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A root cause was unable to be determined.Concomitant medical products: bigliani/flatow modular humeral stem, catalog #: 00430001213, lot #: 60993797; bigliani/flatow modular humeral head, catalog #: 00430004624, lot #: 61168543; cable-ready cerclage cable with crimp, catalog #: 00223200118, lot #: 61365983.This report is number 3 of 5 mdr's filed for the same patient (reference 0001822565-2017-02208, 0001822565-2017-02210, 0001822565-2017-02214, 0001822565-2017-02215).
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