NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONNT RIGHT SIZE F

Additional Manufacturer Narrative

(B)(4). D10 - CONCOMITANT DEVICES - UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE CATALOG #: NI LOT #: NI, NEXGEN POSTERIOR FEMORAL AUGMENT CATALOG #: 00599003601 LOT #: 64461137, NEXGEN DISTAL FEMORAL AUGMENT BLOCK CATALOG #: 00599003620 LOT #: 64038570, NEXGEN LONG STRAIGHT STEM EXTENSION 17MM X 155MM CATALOG #: 00598801117 LOT #: 63634002PERSONA CENTRAL FEMORAL CONE SIZE MEDIUM CATALOG #: 42545001012 LOT #: 64597655, NEXGEN DISTAL FEMORAL AUGMENT BLOCK CATALOG #: 00599003623 LOT #: 64532172, NEXGEN PRECOAT CEMENTED TIBIAL COMPONENT SIZE 6 CATALOG #: 00588000600 LOT #: 66889023, NEXGEN STRAIGHT STEM EXTENSION 15MM X 30MM CATALOG #: 00598801215 LOT #: 65270192 G2: FOREIGN - EVENT OCCURRED IN NEW ZEALAND. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE FEMORAL COMPONENT TO ADDRESS INSTABILITY SECONDARY TO FRACTURE OF THE FEMORAL HINGE PIN AND HINGE POST APPROXIMATELY SIXTEEN (16) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.