(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00105.0001822565-2024-00139.D10: medical products: item#: 00430204619, offset modular humeral head 19 mm head height 46 mm spherical head diameter; lot#: unknown.Item#: unknown, unknown 46 keeled glenoid, lot#: unknown.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital disposed of the product as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.H6: component codes: mechanical (g04) - head.Visual examination of the provided pictures identified an explanted humeral stem.No part or lot information was pictured.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the humeral implant fit is maintained.There is extensive osteolysis of the glenoid with a non-opaque implant.Loosening cannot be excluded.Alignment is abnormal with humeral implant elevation in relation to the glenoid.Bone quality is osteopenic.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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