(b)(4).Report source: foreign : (b)(6).Concomitant associated products: unknown nexel articulation kit, unknown nexel humeral screw kit, unknown nexel humeral component.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001822565 -2020-02336, 0001822565 -2020-02337, 0001822565 -2020-02338.
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It was reported the patient underwent a second revision as the ulnar component was loose proximally and patient was experiencing synovitis.All devices were explanted.Cultures came back negative for infection; however, surgeon elected to treat patient with antibiotics and underwent a two stage revision surgery, where the spacer was removed approximately three months later and implanted with additional zimmer biomet devices.
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