BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    MDR report key: 3856092 · Received March 28, 2014

    Report

    Report Number
    3005673311-2014-00030
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Report Date
    March 10, 2014
    Manufacturer
    AESCULAP AG AND CO KG
    Product Code
    LPH
    PMA / PMN Number
    K040191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: 510(K): K082146; K090299. RESEARCH AND INVESTIGATION HAVE RESULTED IN THE ASSUMPTION THAT THE FOLLOWING AESCULAP AG COMPONENTS ARE INVOLVED IN THIS CASE: NH052T, PLASMACUP SC SIZE 52MM, LOT 51879285; NH103, SC/MSC CERAMICS INSERT 32MM 52/54 SYM., LOT 51788852; NK NK203T, EXCIA PLASMAPORE 12/14 SIZE 13MM, LOT 51876177; NK532K, ISODUR PROSTHESIS HEAD 12/14 32MM XL, LOT UNK; NJ129K, ISODUR PROSTHESIS HEAD 8/10 32MM XL, LOT UNK. UNCLEAR IS, WHY THERE ARE TWO DIFFERENT METAL HEADS MENTIONED IN CONNECTION WITH THIS CASE. AS THE NJ129K HAS A 8/10 CONE, WE ASSUME THAT THE IMPLANTED HEAD WILL BE THE NK532K. METAL HEAD AND CERAMIC INLAY ARE NOT PROVIDED FOR A COMBINATION. AESCULAP'S PRODUCT INFORMATION GIVES THE EXPLICIT NOTE THAT PROSTHESIS HEADS MADE FROM METAL MAY ONLY BE COMBINED WITH INLAYS MADE FROM PE OR XLPE. REVIEW OF THE DHRS OF THE POTENTIALLY INVOLVED COMPONENTS DID NOT SHOW AN INDICATION FOR A MATERIAL OR PRODUCT DEFECT. ADDITIONAL INFORMATION WILL NOT BE PROVIDED BEFORE THE REVISION SURGERY (IF NECESSARY) HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IMPLANTATION OF A PROSTHETIC HIP JOINT IN (B)(6) 2012. FROM THE INFORMATION THAT WAS PROVIDED BY THE PATIENT IT SEEMS THAT A METAL ON CERAMIC COMBINATION WAS IMPLANTED (METAL HEAD/CERAMIC INSERT). PATIENT ALSO REPORTS ABOUT AN INCREASING ION LEVEL IN HER BLOOD AND A REVISION SURGERY PLANNED FOR (B)(6) 2014. THEREFORE, NO PRODUCTS AVAILABLE FOR INVESTIGATION RIGHT NOW. PATIENT WILL PROVIDE HER HEALTH RECORDS THAT SHE HAS RECEIVED FROM THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186640 ISODUR PROSTHESIS HEAD 12/14 32MM XL LPH AND LWJ LPH AESCULAP AG AND CO KG NK532K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other