Section h10: (b2) added check for "hospitalization - initial or prolonged" (d4) expiration date: 10-apr-2022, unique identifier (udi) #: (b)(4).(d5) operator of device: health_care_professional (g1) mdr reporting contact name: (b)(6).(g5) pma/510(k)number: k113309.(h3) the revision reported may have been the result of the glenoid component bottoming out on the glenoid wall upon implantation, possibly related to the small glenoid anatomy, which led to splaying of the posterior inferior peg and ultimate failure.However, the surgeon stated that the patient experienced failure of the rotator cuff which may have led to instability and, as a result, shear stress on the glenoid.Because the explanted device was not returned to exactech for evaluation and no additional x-ray images were provided, specifically an axillary view, it is not possible to determine the underlying cause for this case.(h4) device manufacture date: (b)(6) 2017.*no information provided in the following section(s): a1, a2, a3, a4, a5, b6, b7, e3, g8, h6, h7.
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