BEUDAMED
    FDA Adverse Event Injury Summary report: N

    26MM DIA COCR MOD HD STD NK

    MDR report key: 4750341 · Received May 5, 2015

    Report

    Report Number
    0001825034-2015-01903
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    April 9, 2015
    Report Date
    May 12, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 163622, LOT NUMBER - 874090, EXPIRATION DATE - JUL 31, 2011, MANUFACTURE DATE ¿ JUL 11, 2001. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 163621, LOT NUMBER - 998820, EXPIRATION DATE - JAN 31, 2011, MANUFACTURE DATE ¿ JAN 22, 2001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP REVISION ARTHROPLASTY ON (B)(6) 2002 WHERE THE MODULAR HEAD WAS REPLACED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT WAS REVISED AGAIN ON (B)(6) 2015 DUE TO MULTIPLE DISLOCATIONS. A REVIEW OF INVOICE HISTORY FOR THE (B)(6) 2015 PROCEDURE SUGGEST THE MODULAR HEAD, CUP, AND LINER WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2002. REVIEW OF INVOICE HISTORY SHOWS THAT TWO MODULAR HEADS WERE BILLED; IT IS UNKNOWN WHICH PRODUCT WAS IMPLANTED. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO MULTIPLE DISLOCATIONS. THE MODULAR HEAD WAS REMOVED AND REPLACED WITH BIOMET PRODUCT, WHILE THE ACETABULAR CUP AND LINER WERE REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293213 26MM DIA COCR MOD HD STD NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 874090

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R