(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: item number: 14-107018, item name: freedom constrained modular head, lot #: 916870, item number: 00999601945, item name: femoral body revision stem, lot #: 63021124, item number: unknown, item name: unknown ringloc cup, lot #: unknown, item number: unknown, item name: unknown ringloc liner, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 10896.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|