(b)(4).Concomitant medical products: 115738, 648840, compr nano hmrl pps 38mm 118001, 775140, versa-dial/comp ti std taper 113954, 720760, md hybrid glenoid base 4mm pt-113950, 162240, pt hybrid glen post regenerex unknown unknown palacos cement.Report source foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01497 0001825034 - 2021 - 01498 0001825034 - 2021 - 01500 0001825034 - 2021 - 01501.
|
It was reported that an initial left total shoulder arthroplasty was performed.At the 5-year visit, the patient reported moderate pain, instability, impingement, and loss of range of motion.Glenoid component migration was noted on the x-ray.The patient has been referred for an orthopedic consult but has not yet had any intervention.The outcome is pending.
|