UNK CEMENT RESTRICTOR/PLUG

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED.

Description of Event or Problem

"ARTICLE ENTITLED ¿OCCLUSION AND STABILITY OF TWO DIFFERENT FEMORAL CANAL PLUGS IN CEMENTED HIP ARTHROPLASTY. A PROSPECTIVE AND RANDOMIZED STUDY, WITH A TWO YEAR FOLLOW-UP"" WRITTEN BY K.G. FREUND, S. HOUSHIAN, AND P. RIEGELS-NIELSEN PUBLISHED BY HIP INTERNATIONAL PUBLISHED ON JULY 1, 2003 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO COMPARE THE ABILITY OF TWO DIFFERENT FEMORAL CANAL PLUGS TO PREVENT CEMENT LEAKAGE, DISPLACEMENT, AND EARLY ASEPTIC LOOSENING. 35 PATIENTS IN EACH GROUP WERE EVALUATED OVER A TWO YEAR PERIOD. A COMPETITOR HIP IMPLANT WAS UTILIZED. GROUP 2 (DEPUY SYNTHES) INVOLVED THE FOLLOWING COMPLICATIONS: PATIENTS #3, #26, AND #33 HAD CEMENT LEAKAGE WERE IDENTIFIED IN POSTOPERATIVE RADIOGRAPHS".