BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/48, CODE N

    MDR report key: 9552249 · Received January 6, 2020

    Report

    Report Number
    0009613350-2020-00012
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    August 12, 2019
    Report Date
    January 6, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CLS SPOTORNO, STEM, 125, UNCEMENTED, 10.0, TAPER 12/14; CATALOG NO#: 0100295010; LOT#: 2240389 METASUL LDH, HEAD, 48, CODE N, TAPER 18/20; CATALOG NO#:0100181480 ; LOT#: 2251619 METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20; CATALOG NO#: 0100185146; LOT#: 2253837 CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE: (B)(6) 2019. THE MANUFACTURER DID NOT RECEIVE DEVICES 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 THE USA, 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 USA 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 USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS NOTIFICATION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO HIP BONE FRACTURE, ABRASION-INDUCED BONE LOSS AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16710 METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/48, CODE N DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH N/A 2243836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R