PSN PK CMT FEM LM SZ 4

Description of Event or Problem

IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. THE ACL WAS SLIGHTLY INJURED WITH POSSIBLE PARTIAL AVULSION, LATERAL PLATEAU DAMAGE, WEAR ON LATERAL FEMUR AND A FLOATING PIECE OF BONE ON LATERAL SIDE. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN NEW ZEALAND. D10: 42518200708 66281813 PSN PK VE PLY LM SZ G 8MM, 42538000701 65673837 PSN PK CMT TIB LM SZ G, 4756 SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ FEMUR. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.