STER TROC LAG SCR 100MM

Additional Manufacturer Narrative

DATE SENT TO FDA: 04/05/2004. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem

SURGERY WAS DONE ON (B)(6) 2004 TO REMOVE THE TROCHANTERIC NAIL AND LAG SCREW AND REPLACE IT WITH A BIOPOLAR PROSTHESIS. THE ORIGINAL TROCHANTERIC NAIL FIXATION WAS DONE (B)(6) 2003 TO REPAIR A FRACTURED R. HIP. ON (B)(6) 2003 THE PATIENT WAS RETURNED TO THE O.R. TO REPOSITION THE MIGRATING LAG SCREW. (B)(4).