UNK CEMENT RESTRICTOR/PLUG

Additional Manufacturer Narrative

PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. REVIEWING THE X-RAYS ON THE ARTICLE, NO EVIDENCE HAVE BEEN FOUND OF AN IMPLANT FRACTURE, DISASSOCIATION OY ANYTHING INDICATIVE OF A DEVICE NON-CONFORMANCE. NO EVIDENCE HAVE BEEN FOUND OF A CEMENT FAILURE OR NON-CONFORMANCE. THERE IS NO EVIDENCE TO CONFIRM ANY ISSUE OF THE PRODUCTS. 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 MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE.

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 ¿PROSPECTIVE RANDOMIZED CONTROL TRIAL COMPARING BIOSTOP, A BIOABSORBABLE CEMENT RESTRICTOR WITH THE STANDARD HARDINGE CEMENT PLUG "" WRITTEN BY A. MOFIDI, H. KAPOOR, R. KUMAR, J. RICE, H. SMYTH, G. C. FENELON, J. MCELWAIN, D. BORTON, PUBLISHED ONLINE 18 FEBRUARY 2004, WAS REVIEWED. THIS STUDY IS A RANDOMIZED CONTROL TRIAL COMPARING THE EFFECTIVENESS OF BIOSTOP, AN ABSORBABLE CEMENT RESTRICTOR WITH HARDINGE, A NONABSORBABLE CEMENT RESTRICTOR IN 136 CONSECUTIVE PATIENTS WHO HAD A CHARNLEY TOTAL HIP REPLACEMENT INSERTED. TYPE OF CEMENT RESTRICTOR, THE SURGICAL APPROACH, THE SURGEON, THE VISCOSITY OF THE CEMENT, THE CEMENTING TECHNIQUE, AND THE FEMORAL CANAL DIAMETER WERE STATISTICALLY COMPARED TO THE DISTAL MIGRATION OF THE CEMENT. WE FOUND NO STATISTICAL DIFFERENCE BETWEEN ANY OF THESE VARIABLES. IN CONCLUSION, BIOSTOP IS AS EFFECTIVE AS THE HARDINGE CEMENT RESTRICTOR, AND IN THE PRESENCE OF ADEQUATE CEMENT RESTRICTION, THE ABOVE FACTORS IN VIVO HAVE LITTLE EFFECT IN DISTAL MIGRATION OF THE CEMENT MANTLE. 136 CONSECUTIVE TOTAL HIP REPLACEMENTS WERE PERFORMED. THE FIRST GROUP (GROUP A) HAD A BIOSTOP CEMENT RESTRICTOR INSERTED AND THE OTHER GROUP (GROUP B) HAD A HARDINGE CEMENT RESTRICTOR INSERTED DURING THE INSERTION OF THE CEMENTED FEMORAL COMPONENT. EVERY PATIENT RECEIVED THE PRIMARY CHARNLEY FEMORAL PROSTHESIS WITH PALACOS R-20, HOMEDICA CEMENT, WHICH WAS VACUUM MIXED IN A STANDARD FASHION. THERE WAS MENTION OF CEMENT MIGRATION, THE AUTHORS FOUND NO CORRELATION BETWEEN ANY OF THE ABOVE VARIABLES DURING CEMENTING AND DISTAL MIGRATION OF THE CEMENT AS MEASURED BY THE POSTOPERATIVE RADIOGRAPH. ALTHOUGH WE SAW A SIGNIFICANT RANGE IN THE DISTAL MIGRATION OF THE CEMENT RESTRICTOR (23±19 MM, RANGE 0¿72 MM), WE FOUND NO RELATIONSHIP BETWEEN ANY OF THESE FACTORS AND DISTAL MIGRATION OF CEMENT AND THE CEMENT RESTRICTOR. THIS LED US TO CONCLUDE THAT IN THE PRESENCE OF ADEQUATE CEMENT RESTRICTION, THESE FACTORS HAVE LITTLE EFFECT IN DISTAL MIGRATION OF THE CEMENT MANTLE. THE DIFFERENCE IN THE CEMENT MIGRATION, IF NOT CAUSED BY THE MEASURED VARIABLES IN THIS STUDY, MAY BE AN INDICATOR OF AND BE CAUSED BY THE SUCCESS IN CEMENT PRESSURIZATION. IT SHOULD BE NOTED THAT CEMENT RESTRICTOR ACTS AS ANOTHER FOREIGN BODY AND CAN CAUSE FOREIGN-BODY REACTION AND BECOME A SOURCE FOR PARTICULATE DEBRIS, BUT THERE WERE NO PATIENT HARMS NOTED, NO REVISION, NOR INVASIVE TREATMENT NOTED IN THIS STUDY."