(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42504607002 persona femur cemented std right size 11 lot# 64532701.42545001012 persona femoral central cone size medium lot# 64189936.42556807005 persona femoral post augment cemented size 11, 11+5mm lot# 64485584.42556607005 persona femoral dist augment cemented size 11, 11+5mm lot# 64664231.42560113520 persona stem ext straight splined uncemented 20mm dia 135mm l lot# 64635804.42542007902 persona tibia fixed cemented right size g lot# 64334603.42560613514 persona stem ext 6mm offset splined uncemented 14mm dia 135mm l lot# 64729231.42545000513 persona tibial central cone size large lot# 64189641.
|