BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR CUP 28X49MM

    MDR report key: 3813360 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04136
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    June 24, 2008
    Report Date
    July 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    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: "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04135, 04136 & 04138).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A BI-POLAR RIGHT HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2006 AND SUBSEQUENTLY ALLEGED PAIN. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 AND ALLEGED THAT BLACKISH FILM FROM METAL THREADING WAS NOTED DURING THE REVISION. LEGAL COUNSEL FOR PATIENT REPORTED THAT A SECOND REVISION PROCEDURE OCCURRED ON (B)(6) 2008 DUE TO PATIENT ALLEGATIONS OF INSTABILITY. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE AND THE DATE OF THE FIRST REVISION PROCEDURE. INVOICE HISTORY SUGGESTS THE BI-POLAR ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD DURING THE FIRST REVISION SURGERY. AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE SECOND REVISION SURGERY OR WHAT WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT RIGHT HIP REVISION PERFORMED ON (B)(6) 2008 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED BLACKISH FILM; ACETABULAR CUP AND MODULAR HEAD REMOVED. THE CUP WAS REPLACED WITH A COMPETITOR'S. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT RIGHT HIP REVISION PERFORMED ON (B)(6) 2008 WAS DUE TO HIP INSTABILITY. THE PATIENT'S OPERATIVE REPORT NOTED COMPETITOR'S CUP AND BIOMET HEAD WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A BI-POLAR RIGHT HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2006 AND SUBSEQUENTLY ALLEGED PAIN. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 AND ALLEGED THAT BLACKISH FILM FROM METAL THREADING WAS NOTED DURING THE REVISION. LEGAL COUNSEL FOR PATIENT REPORTED THAT A SECOND REVISION PROCEDURE OCCURRED ON (B)(6) 2008 DUE TO PATIENT ALLEGATIONS OF INSTABILITY. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE AND THE DATE OF THE FIRST REVISION PROCEDURE. INVOICE HISTORY SUGGESTS THE BI-POLAR ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD DURING THE FIRST REVISION SURGERY. AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE SECOND REVISION SURGERY OR WHAT WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290052 RINGLOC BI-POLAR CUP 28X49MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 263920

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R