BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT CENTRALIZER/PLUG

    MDR report key: 24935879 · Received April 21, 2026

    Report

    Report Number
    1818910-2026-07178
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    January 1, 2000
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GABBAR OA, WILLIAMS RW, SPENCER RF. FRAGMENTATION OF THE POLYETHYLENE CEMENT RESTRICTOR IN TOTAL HIP ARTHROPLASTY. HIP INTERNATIONAL. 2000;10(2):123-126. DOI:10.1177/112070000001000209. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY EXAMINED THE DIMENSIONS AND NUMBER OF DISTAL RADIOLUCENCIES IN THE CEMENT AND THEIR CORRESPONDENCE WITH THE WING SIZE OF THE RESTRICTOR, METHOD OF SUCTION USED DURING PRESSURISED LAVAGE, PROXIMAL AND DISTAL CANAL DIAMETER AND AMOUNT OF TAPER, AND GRUEN ZONE LOCATION OF RADIOLUCENCIES. GROUP 1 CONSISTED OF 54 PATIENTS WITH CONSECUTIVE TOTAL HIP REPLACEMENTS PERFORMED RECENTLY IN WHOM DISTAL SUCTION OF THE MEDULLARY CAVITY WAS PERFORMED DURING LAVAGE. GROUP 2, CONSISTED OF 35 PATIENTS PERFORMED IN THE YEARS 1992-1993, AGAIN CONSECUTIVELY, IN WHICH PROXIMAL SUCTION ONLY WAS USED. ALL PATIENTS HAD STANDARD AP AND LATER AL PRE- AND POST-OPERATIVE X-RAYS OF THE HIP. THE HARDINGE CEMENT RESTRICTOR WAS EMPLOYED IN ALL CASES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: HARDINGE CEMENT RESTRICTOR ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CEMENT RESTRICTOR/PLUG (QTY 17): N=17 DETACHED FRAGMENTS - NO INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251878 CEMENT CENTRALIZER/PLUG JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1