CUSTOM PROXIMAL HUMERUS

Additional Manufacturer Narrative

THE INVESTIGATION REVEALED A POSSIBLE DIMENSIONAL DISCREPANCY BETWEEN THE HUMERAL IMPLANT AND THE LINER IMPLANT THAT MAY HAVE IMPACTED THE FULL SEATING OF THE POLYETHYLENE LINER. THE LINER WAS ULTIMATELY CEMENTED INTO THE HUMERAL IMPLANT AND THERE IS LITTLE EXPECTED FURTHER RISK OF DISASSOCIATION BETWEEN THE COMPONENTS IN QUESTION.

Description of Event or Problem

A CUSTOM PROXIMAL HUMERUS RECONSTRUCTION IN CONJUNCTION WITH A REVERSE TOTAL SHOULDER HAD TO BE REVISED A SECOND TIME DUE TO POLYETHYLENE LINER DISASSOCIATION. THE INITIAL DISASSOCIATION EVENT INVOLVED THE PATIENT REPORTING MINOR TRAUMA, REACHING INTO GLOVE BOX AS CAR STOPPED WHICH CAUSED THE DISASSOCIATION. FOLLOWING INITIAL REVISION SURGERY, THE PATIENT DISLOCATED AGAIN PROMPTING THE SURGEON TO REVISE AGAIN.