UNK CEMENT RESTRICTOR/PLUG

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PHOTOGRAPHS PROVIDED WITHIN THE JOURNAL ARTICLE ARE NOT GOOD QUALITY IMAGES. IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED ALLEGATION. NOTHING INDICATIVE OF A PRODUCT PROBLEM IS IDENTIFIED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ARTICLE ENTITLED "RESORBABLE VERSUS NONRESORBABLE INTRAMEDULLAR CEMENT RESTRICTOR IN A PROSPECTIVE AND RANDOMIZED STUDY WITH A 2-YEAR FOLLOW-UP" WRITTEN BY KNUD GADE FREUND, NIELS HEROLD, NIELS D ROCK, AND PER RIEGELS-NIELSEN PUBLISHED BY ACTA ORTHOPAEDICA SCANDINAVICA ON JANUARY1, 2003, WAS REVIEWED. THE STUDY WAS DESIGNED TO COMPARE THE RESTRICTOR TO A NONRESORBABLE POLYETHYLENE RESTRICTOR, AS REGARDS PROBABLE MIGRATION OF THE RESTRICTOR, CEMENT LEAKAGE AND EARLY ASEPTIC LOOSENING. 70 PATIENTS WERE INCLUDED WITH THE STUDY. ALL WERE IMPLANTED WITH A COMPETITOR STEM AND CEMENT. 35 HAD A COMPETITOR CEMENT RESTRICTOR PLACED AND REMAINING 35 HAD DEPUY SYNTHES CEMENT RESTRICTOR PLACED. THERE WAS NO MENTION OF THE REMAINING IMPLANTS. FOLLOW UP WAS 2-YEARS DURING FOLLOW UP, 10 PATIENTS DIED OF CAUSES UNRELATED TO THR. 2 WERE TOO SICK TO UNDERGO A RADIOGRAPHIC EVALUATION AND 1 LATER DISARTICULATED BECAUSE OF SEVERE GANGRENE. IT¿S UNKNOWN WHICH CEMENT RESTRICTOR WAS INVOLVED WITH THESE TWO PATIENTS AND WHY THE OTHER PATIENT WAS ¿TOO SICK¿ TO UNDERGO RADIOGRAPHS. THIS LEFT 56 PATIENTS OVERALL AND 25 INVOLVING DEPUY SYNTHES CEMENT RESTRICTOR. ADVERSE EVENT INVOLVING DEPUY ¿ SYNTHES PRODUCTS: CASE 49 HAD LEAKAGE AROUND THE CEMENT RESTRICTOR ¿ NO INTERVENTION NOTED. CASE 64 HAD LEAKAGE AROUND THE CEMENT RESTRICTOR ¿ NO INTERVENTION NOTED. CASE 66 HAD LEAKAGE AROUND THE CEMENT RESTRICTOR ¿ NO INTERVENTION NOTED. ONE PATIENT SUSTAINED A LEG AMPUTATION DUE TO INFECTION ¿ UNKNOWN WHICH CEMENT RESTRICTOR WAS INVOLVED.