BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 52/46 L

    MDR report key: 8389607 · Received March 5, 2019

    Report

    Report Number
    0009613350-2019-00103
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    April 2, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K053536
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY: DATE DETAIL OF PRODUCT- ITEM NUMBER: 0100181460, ITEM NAME: METASUL® LDH®, HEAD, 46, CODE L, TAPER 18/20, LOT # 2412084; ITEM NUMBER: 0100185146, ITEM NAME: METASUL® LDH®, HEAD ADAPTER, M, 0, TAPER 12/14-18/20, LOT # 2424834; ITEM NUMBER: 00-7864-014-00, ITEM NAME: TM PRIM FEM ST 14MM, LOT # 60816155. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION, NEITHER X-RAYS, BUT RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. COMPLEX PHYSIOLOGICAL REACTIONS LIKE PSEUDOTUMOR OR METAL ALLERGY ARE KNOWN RISKS FOR THIS KIND OF METAL-ON-METAL IMPLANTS AS STATED IN ZIMMER¿S INSTRUCTION LEAFLET FOR ENDOPROSTHESIS NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED IN (B)(4) (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). AT LEAST ONE OF THESE ERROR PATTERNS IS OBSERVED IN THIS EVENT. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL RE-EVALUATE THE CASE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM FOLLOWING A REVISION SURGERY DUE TO PAIN, METALLOSIS AND FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182936 DUROM US ACETABULAR COMPONENT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS KWA ZIMMER GMBH N/A 2414237

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R