BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R/B RLOC LHOLE SHL 50MM SZ 23

    MDR report key: 5490000 · Received March 9, 2016

    Report

    Report Number
    0001825034-2016-00847
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    December 15, 2015
    Report Date
    February 11, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK050124
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY.¿ NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00092-2 / 00847 / 00848 / 00849).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PAIN AND LOOSENING OF THE CUP. DURING THE PROCEDURE, OSTEOLYSIS AROUND THE BONE SCREWS AND RETROGRADED CUP WERE NOTED. THE CUP, HEAD AND LINER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED WELL FIXED FEMORAL COMPONENT, MINIMAL CORROSION ON THE TRUNNION, BEARING SURFACE WEAR AND CUP IN RETROVERTED POSITION. IT WAS FURTHER REPORTED A SCREW BROKE AND WAS RETAINED BY THE PATIENT DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145510 R/B RLOC LHOLE SHL 50MM SZ 23 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 940830

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R