BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL PRESS-FIT FEMORAL STEM

    MDR report key: 3201694 · Received June 28, 2013

    Report

    Report Number
    1822565-2013-01038
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    February 13, 2009
    Report Date
    May 13, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRIMARY OPERATIVE NOTES WERE NOT RETURNED, AND THUS PERI- AND POST-OPERATIVE PROPHYLAXIS IS UNK. REVISION SURGICAL NOTES WERE PROVIDED WHICH REVEALED THAT THE PT HAD PURULENT MATERIAL EXPRESSED FROM THE LOWER PART OF THE INCISION. THE PT HAS A HISTORY OF IV HEROIN USE. UPON ENTERING THE JOINT, FURTHER PURULENT MATERIAL WAS ENCOUNTERED AROUND THE FEMUR. TOBRAMYCIN IMPREGNATED CEMENT WAS USED. THE SECOND STAGE OPERATIVE NOTES WERE PROVIDED WHICH STATE THAT THE GLUTEUS MEDIUS WAS NECROTIC ANTERIORLY AND CAREFUL DISSECTION WAS CARRIED OUT. DEBRIDEMENT WAS PERFORMED AND AFTER EXPOSURE OF THE FEMUR, NO PURULENCE WAS OBTAINED AT ANY POINT, HOWEVER A SMALL AMOUNT OF SYNOVIAL FLUID WAS ENCOUNTERED UPON ENTERING THE PSEUDOCAPSULE. THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT A 2 STAGE REVISION FOR INFECTION. THE COMPONENTS WERE EXPLANTED ON (B)(6) 2009 AND AN IMPREGNATED ANTIBIOTIC SPACER WAS IMPLANTED. FINAL COMPONENTS WERE IMPLANTED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296968 TRABECULAR METAL PRESS-FIT FEMORAL STEM LPH ZIMMER INC 60969621

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention