BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 398339 · Received June 4, 2002

    Report

    Report Number
    MW1025233
    Event Type
    Injury
    Date Received
    June 4, 2002
    Report Date
    May 17, 2002
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/29/02: AS OF JULY 18, 2002, THE NUMBER OF CONFIRMED REVISIONS OF THE RECALLED ACETABULAR SHELLS REPORTED TO SULZER ORTHOPEDICS INC IS 2,985.

    Description of Event or Problem · 1

    DEFECTIVE IMPLANT UNBONDED. REQUIRED SURGERY TO REPLACE WITH NEW ONE. RPTR HAD A HIP REPLACEMENT IMPLANT SURGERY IN WHICH AN INTER-OP ACETABULAR SHELL HIP IMPLANT WAS SURGICALLY IMPLANTED BY A BOARD CERTIFIED ORTHOPEDIC SURGEON. A MFG DEFECT PREVENTED THE INTER-OP SHELL FROM BONDING WITH THE ACETABULUM. SUCH WAS CONTAMINATED WITH AN OIL RESIDUE WHEN MFG. ONE SHELL CAME UNBONDED FROM THE ACETABULUM WHILE RPTR WAS WALKING WHICH INJURED THEM. THEY HAD TO HAVE A REVISION HIP REPLACEMENT CONDUCTED IN WHICH A SECOND SULZER ORTHOPEDICS INC. INTER-OP ACETABULAR SHELL HIP IMPLANT HAD TO BE IMPLANTED AND THE FIRST DEFECTIVE ONE REMOVED. SULZER ORTHOPEDICS INC DESIGNS, MANUFACTURES AND DISTRIBUTES ORTHOPEDIC IMPLANTS FOR HIPS, KNEES, SHOULDERS AND ELBOWS. ITS INTER-OP SHELL IS ONE COMPONENT OF A SYSTEM USED FOR COMPLETE HIP REPLACEMENTS. SPECIFICALLY, THE INTER-OP SHELL IS A SOCKET-LIKE DEVICE INSERTED INTO THE ACETABULUM WHICH IS A PART OF THE PELVIS; THE SHELL IS DESIGNED TO RECEIVE A SEPARATE BALL-LIKE DEVICE, WHICH IS INSERTED INTO THE FEMUR OR THE THIGH BONE. THE TWO COMPONENTS THEREBY REPLACE THE ARTICULATING BALL-AND-SOCKET STRUCTURE OF THE HIP JOINT. THIS INTER-OP SHELL IS REGULATED BY THE FOOD AND DRUG ADMINISTRATION (FDA), THEREFORE RPTR IS REGISTERING THIS ABOVE AND FOREGOING COMPLAINT WITH FDA CONCERNING THIS DEFECTIVE MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTER-OP ACETABULAR SHELL HIP IMPLANT KWB SULZER ORTHOPEDICS, INC. * 1312804

    Patients

    Seq Age Sex Outcome Treatment
    1 *