BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 48/42 CODE H

    MDR report key: 9791760 · Received March 5, 2020

    Report

    Report Number
    0009613350-2020-00100
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    October 15, 2019
    Report Date
    March 5, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K053536
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT LIST: METASUL LDH HEAD ADAPTER, M, 0, TAPER 12/14-18/20;PART#0100185146; LOT#2377184, METASUL LDH HEAD, 42, CODE H, TAPER 18/20; PART#0100181420; PART#2367403, FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 10 EXTENDED OFFSET; PART#00771101020; LOT#60564465, PALACOS RG 1X40 SINGLE; PART#00111314001; PART#65634103. 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. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO PAIN, ELEVATED METAL IONS LEVELS, METALLOSIS, HYPERTROPHIC SYNOVIUM AND SIGNS OF OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254976 DUROM ACETABULAR COMPONENT 48/42 CODE H DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2361368

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R