UNILATERAL KNEE JOINT

Additional Manufacturer Narrative

THE ORTHOTIC KNEE JOINT OPENED UNINTENTIONALLY. THE PATIENT FELL AND BROKE HER LEG. THE PATIENT WENT TO HER CLINICIAN. HE COULD NOT REPLICATE THE UNLOCK ISSUE AND DIDN'T FIND ANYTHING BROKEN OR MISSING. THE ORTHOSIS HAS BEEN SENT IN AND EXAMINED. THERE IS EVIDENCE OF WEAR ON THE ORTHOSIS, BUT THIS IS THE COURSE OF NORMAL WEAR AND TEAR. THE HARDNESS MEASUREMENT HAS SHOWN THAT THE MATERIAL FOR THE UPPER AND LOWER JOINT SECTIONS IS WITHIN THE SPECIFICATION. THE RIGID DESIGN OF THE ORTHOSIS AND THE BILATERAL USE OF THE KNEE JOINTS LARGELY PREVENT THE SUPERIMPOSITION OF TORSION AND BENDING MOMENTS, SO THERE IS NO MECHANICAL DEFORMATION OR TWISTING IN THE JOINTS. THE LOCK WEDGES ARE NOT CONNECTED DIRECTLY TO EACH OTHER, BUT FLEXIBLY CONNECTED BY A PERLON CABLE, WHICH CAN BE CENTRALLY OPERATED BY A HANDLE. IN ADDITION, THE LOCK WEDGES ARE DECOUPLED FROM EACH OTHER AND THE USE OF THE PERLON CABLE TO FORM A GRIP PREVENTS THE POSSIBILITY OF DIRECT INFLUENCE FROM ONE JOINT TO ANOTHER. NO MALFUNCTION OF THE JOINTS WAS FOUND. UNPLANNED OPENING OF THE JOINTS COULD NOT BE REPRODUCED. ACCORDING TO THE INVESTIGATION FINDINGS, THE KNEE JOINTS THAT WERE USED ARE NOT THE CAUSE OF THE PATIENT'S FALL.

Description of Event or Problem

ACCORDING TO THE PATIENT THE JOINT INADVERTENTLY UNLOCKED. SHE FELL AND BROKE HER LEG.

Description of Event or Problem

ACCORDING TO THE PATIENT THE JOINT INADVERTENTLY UNLOCKED. SHE FELL AND BROKE HER LEG.

Additional Manufacturer Narrative

THE ORTHOTIC KNEE JOINT OPENED UNINTENTIONALLY. THE PATIENT FELL AND BROKE HER LEG. THE PATIENT WENT TO HER CLINICIAN. HE COULD NOT REPLICATE THE UNLOCK ISSUE AND DIDN'T FIND ANYTHING BROKEN OR MISSING. CURRENTLY THE KNEE JOINTS (RIGHT AND LEFT) ARE ON THE WAY TO GERMANY. THEREFORE, WE COULD NOT COMPLETE OUR INVESTIGATION. WE WILL SEND THE FINAL REPORT, ONCE THE INVESTIGATION IS COMPLETED.