(b)(4).D10 medical devices: persona femur cemented (ps) standard right size 6, catalog#: 42500606002, lot#: 63945121.Persona art.Surf.Fixed bearing (ps) right 11 mm height, catalog#: 42522400711, lot#: 64013879.Persona stem extension tapered cemented 14 mm diameter +30 mm, catalog#: 42557000114, lot#: 64069281.G2 foreign source: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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