BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARRIS GALANTE POROUS CUP, 52 MM O.D.

    MDR report key: 2234 · Received January 14, 1993

    Report

    Report Number
    32821-1992-00019
    Event Type
    Injury
    Date Received
    January 14, 1993
    Date of Event
    December 4, 1992
    Report Date
    December 16, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUP LINER APPARENTLY WAS DISLOCATED FROM THE SHELL BECAUSE OF REPEATED FALL BY PATIENT RECENTLY ACCORDING TO THE SURGEON. THE CUP WITH SCREWS WAS INTACT, HOWEVER THE STANDARD 28 MM LINER WAS ERODED AROUND THE RIM'S SUPERIOR MARGIN WITH EXPOSURE OF RADIO-OPAQUE WIRE. THE FEMORAL HEAD WAS BURNISHED WITH A BLACK SPOT FROM MOTION AGAINST EXPOSED METAL SURFACE OF CUP. PHYSICIAN REPLACED POLY WITH A ELEVATED LINER AND A FEMORAL HEAD. UPON INSPECTION OF "WHOLE TALE" TABS ON THE HGP I CUP, 3 OF 6 WERE BROKEN OFF THE CUP RENDERING LOOSE THE REPLACEMENT LINER'S FIT. INSTEAD OF DISTURBING THE BONY INGROWTH OF THE CUP THROUGH REPLACEMENT, THE SURGEON ELECTED TO LEAVE THE CUP INTACT, AND CEMENT (SIMPLEX P) THE ELEVATED LINER INTO THE HGP I SHELL IN APPROPRIATE APPOSITIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARRIS GALANTE POROUS CUP, 52 MM O.D. Implant HGP I CUP, 52 MM O.D. MBL ZIMMER, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention