BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2855357 · Received November 28, 2012

    Report

    Report Number
    9613350-2012-01082
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    June 26, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MER GMBHZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 (B)(4) AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE US. 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 AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED AN ACETABULAR CUP, RIGHT SIDE BETWEEN (B)(6) 2005 AND (B)(6) 2005 AND WAS REVISED BETWEEN (B)(6) 2012 AND (B)(6) 2012. DUE TO HUGE OSTEOLYSES PROXIMALES FEMUR WITH EXTENSIVE BURSITIS TROCHANTERICA AND GREAT SEROME CAVITY WITH METAL ABRASION IN THE CONE AREA. MOREOVER IMPINGEMENT DUE TO OSTEOPHYTES ON THE ACETABULAR CUP AND PAROXYSMAL ATRIAL FIBRILLATION WERE REPORTED. (NOTE ASSUMING PT JOINED HOSPITAL ONE DAY PRIOR TO THE SURGERY DATES WERE CHOSEN AS FOLLOWS: PRODUCT IMPLANTED ON (B)(6) 2005 AND REVISED ON (B)(6) 2012).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA MER GMBHZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R