BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD STD NK

    MDR report key: 3901975 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05789
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    October 15, 2010
    Report Date
    July 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: 14. POSTOPERATIVE BONE FRACTURE AND PAIN. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    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 REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05789 /-07097).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, LEGAL COUNSEL REPORTS THAT PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND LOSS OF RANGE OF MOTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2010 DUE TO PAIN AND A FLUID COLLECTION. OPERATIVE REPORT NOTED THE PRESENCE OF CLOUDY FLUID WITH WHITE PARTICULATE MATTER, A CYST BEHIND THE CUP, AND LACK OF BONY INGROWTH ON THE CUP. THE MODULAR HEAD, LINER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR'S CUP AND A BIOMET HEAD.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, LEGAL COUNSEL REPORTS THAT PATIENT¿S RIGHT HIP WAS REVISED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND LOSS OF RANGE OF MOTION. 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
    380038 32MM M2A MOD HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 797190

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R