BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM COCR MOD HD +6MM NO SKIRT - SALVAGE/ONOCOLOGY HIP

    MDR report key: 4173362 · Received October 15, 2014

    Report

    Report Number
    0001825034-2014-08143
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 14 STATES ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT WHO HAD MULTIPLE REVISIONS SPANNING 18 YEARS (REFERENCE 1825034-2014- 07946 & 08143 / 08145).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS ON (B)(6) 1997, (B)(6) 1998, AND (B)(6) 2000. THE PATIENT WAS AGAIN REVISED ON (B)(6) 2014 DUE TO A FEMORAL FRACTURE SUSTAINED FROM A PATIENT FALL. A COMPETITOR STEM AND HEAD WERE REMOVED AND REPLACED BY A COMPETITOR STEM AND HEAD. THE RINGLOC LINER WAS ALSO REMOVED AND REPLACED BY A NEW LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655930 28MM COCR MOD HD +6MM NO SKIRT - SALVAGE/ONOCOLOGY HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 354500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R