BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2930445 · Received January 23, 2013

    Report

    Report Number
    9613350-2013-01291
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 22, 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 DEICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE OF 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. SHOULD ADDITIONAL INFORMATION INCLUDING THE RETURN OF THE PRODUCTS FOR INVESTIGATION, 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. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED AN ACETABULAR COMPONENT WITH AN INITIAL SURGERY (B)(6) 2006. ONE WEEK AFTER INITIAL SURGERY, ON (B)(6) 2006, PT UNDERWENT REVISION SURGERY TO UPSIZE ML TAPER STEM. A NEW METASUL ADAPTER ((B)(4)) WAS USED. ON (B)(6) 2012, SAME PT UNDERWENT REVISION FOR THE FOLLOWING DIAGNOSIS: PSEUDOTUMOR, PAIN, NO BONE GROWTH ON CUP. ELEVATED METAL ION LEVELS WAS ALSO MENTIONED. THE PT ALSO SUFFERED FORM ALOPECIA OF UNK REASON. AT THE REVISION SURGERY, NO LOOSENING WAS OBSERVED BY THE SURGEON. ALVAL SCORE WAS 5/10, SO THE PATHOLOGY DID NO SHOW A PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33164 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONETN 48/42 CODE H KWA ZIMMER GMBH 2309171

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention