(b)(4).Concomitant devices: trabecular metal tibial cone, medium 31x31mm catalog #: 00545001331 lot #: 64700231; tibial component precoat size 2 catalog #: 00588000200 lot #: 64146578; stem extension straight 12.7 mm dia.X 30 mm length (combined length 75 mm)catalog #: 00598801212 lot #: 62762283; trabecular metal femoral metaphyseal cone, 35mm, small, left ; catalog #: 00545002035 lot #: 64249422; stem extension straight: long 14mm dia x 155mm length(combined length 200mm) catalog #: 00598801114 , lot #: 63240767; prc agmt block dist sz e 10mm catalog #: 00-5990-035-20 lot #: 62708077; prc agmt block dist sz e 10mm catalog #: 00-5990-035-20 lot #: 63789533; prc agmt block dist sz e 5mm catalog #: 00-5990-035-01 lot #: 63832525; prc agmt block dist sz e 5mm catalog #: 00-5990-035-01 lot #: 64630746; the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested from hospital and not returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reference report: 0001822565 - 2021 - 01943, 0001822565 - 2021 - 01965.
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