PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

CLINICAL STUDY#: (B)(4). PATIENT#: (B)(6) REPORTED THE FOLLOWING ADVERSE EVENT: HIP DISLOCATION. DISLOCATION WAS TREATED WITH CLOSE REDUCTION. THIS ADVERSE EVENT DID NOT END IN RE-REVISION SURGERY. NO FURTHER INFORMATION IS PROVIDED DUE TO PRIVACY POLICIES.

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. MPO WAS MADE AWARE OF THIS INCIDENT THROUGH A CLINICAL STUDY PERFORMED USING MPO IMPLANTS. IT IS UNKNOWN WHEN THIS INCIDENT OCCURRED OR HOW LONG THE IMPLANTS WERE IMPLANTED PRIOR TO THE INCIDENT. THESE IMPLANTS WERE NOT RETURNED FOR INVESTIGATION, NOR WERE ANY PICTURES PROVIDED TO ASSIST WITH THE INVESTIGATION. MEDICAL DATA WAS PROVIDED WHICH LISTED IMPLANT INFORMATION SUCH AS THE LOT NUMBERS. THESE IMPLANTS WERE MANUFACTURED IN 2007 (PHA00612 AND PHA02858), 2008 (PHA03858), 2010 (PHA04410), AND 2011 (PHA01232). REVIEW OF THE DESIGN HISTORY RECORDS (DHR) FOR THE SUBJECT MANUFACTURING LOTS INDICATE THAT THESE IMPLANTS WERE MANUFACTURED TO SPECIFICATION. IT CANNOT BE CONCLUDED WHAT LEVEL OF CONTRIBUTION, IF ANY, THAT THE PRODUCT HAD TO THE COMPLAINT. NO FURTHER EVALUATIONS CAN BE MADE WITHOUT RETURN OF THE PRODUCT OR RECEIPT OF OTHER CLINICAL INFORMATION. THE MPO HIP SYSTEMS PACKAGE INSERT (150803-9) LISTS. DISLOCATION, MIGRATION AND/OR SUBLUXATION OF PROSTHETIC COMPONENTS FROM IMPROPER POSITIONING, TRAUMA, LOSS OF FIXATION AND/OR MUSCLE AND FIBROUS TISSUE LAXITY; AS A POTENTIAL ADVERSE EFFECT OF TOTAL HIP ARTHROPLASTY. ADDITIONALLY, IT ALSO STATES PERIODIC, LONG-TERM FOLLOW-UP IS RECOMMENDED TO MONITOR THE POSITION AND STATE OF THE PROSTHETIC COMPONENTS, AS WELL AS THE CONDITION OF THE ADJOINING BONE. PERIODIC POST-OPERATIVE XRAYS ARE RECOMMENDED FOR CLOSE COMPARISON WITH EARLY POST-OP CONDITIONS TO DETECT LONG TERM EVIDENCE OF CHANGES IN POSITION, LOOSENING, BENDING, OR CRACKING OF COMPONENTS. MPO WILL CONTINUE TO MONITOR THIS ISSUE THROUGH COMPLAINT TRACKING.