BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR CUP

    MDR report key: 3764898 · Received April 22, 2014

    Report

    Report Number
    0001825034-2014-03077
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 1, 2012
    Report Date
    September 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS PRODUCT WAS NOT IMPLANTED AS PREVIOUSLY REPORTED. THIS MDR IS CONSIDERED CLOSED. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03075 /-03077 /-03078 /-03079 /-07616).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A REVIEW OF THE INVOICE FROM THE INITIAL SURGERY FOUND THAT TWO ACETABULAR CUPS WERE LISTED. IT IS NOT KNOWN WHICH CUP WAS IMPLANTED. REVIEW OF DEVICE HISTORY RECORDS FOR BOTH CUPS SHOW THAT THE LOTS RELEASED WITH NO RECORDED ANOMALIES OR DEVIATIONS. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ (B)(4). LOT NUMBER ¿ 204800, OR 061990, EXPIRATION DATE ¿ MAY 31, 2014, MANUFACTURE DATE ¿ MAY 17, 2004 OR MAY 28, 2004, THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03075/03077 & 03079).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, DAMAGE TO BONE AND TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP ON (B)(6) 2012 AND A REVISION PROCEDURE OF THE LEFT HIP ON (B)(6) 2011. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE FOR THE LEFT HIP AND THE REVISION SURGERY DATE FOR THE RIGHT HIP; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE INITIAL SURGERY DATE FOR THE RIGHT HIP AND THE REVISION SURGERY DATE FOR THE LEFT HIP. 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
    243170 UNKNOWN ACETABULAR CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R