(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mdr (b)(4), 0001822565-2021-00919.Concomitant medical products: item#: 00430205219, offset modular humeral head 19 mm head height 52 mm spherical head diameter; lot#: unknown.Item#: 47430103100, drill with stop bigliani/flatow the complete shoulder solution: lot#: unknown.Item#: 00430103401, keel sponge single use only; lot#: unknown.Item#: 00430103501, pressurizer sponge; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|