BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 56/50 CODE P

    MDR report key: 3040048 · Received April 3, 2013

    Report

    Report Number
    9613350-2013-01465
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WITH THE INFORMATION GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. A TISSUE REACTION LIKE A PSEUDO TUMOR CAN BE A POST-OPERATIVE RISK FOR METAL ON METAL (MOM) IMPLANTS IN GENERAL AS ALSO STATED IN ZIMMER'S INSTRUCTION FOR USE (D011500200). BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE U.S., ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE U.S WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE U.S. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE U.S. AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS CORRECTION Z-2415/2426-2008. SHOULD ADDITIONAL INFORMATION INCLUDING THE FINAL INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM ACETABULAR COMPONENT 56/50 CODE P ON (B)(6) 2008 AND UNDERWENT REVISION SURGERY ON (B)(6) 2013 DUE TO PSEUDOTUMOR AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135913 DUROM ACETABULAR COMPONENT 56/50 CODE P DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R