(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: (b)(4).Concomitant medical products: 00434901013, humeral stem 10 mm stem diameter 130 mm stem length, lot 61966843; 00434903909, humeral stem spacer size 9, lot 61994540; 00434903611, glenosphere 36 mm diameter, lot 61955402; 00434903811, base plate uncemented, lot 61990797.
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It was reported that approximately five (5) years post implantation of a reverse total shoulder arthroplasty, the patient had developed grade 4 scapular notching, found on radiograph.There has been no medical intervention as of now.Attempts have been made and no further information has been provided.
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