BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHELL SZ 41/58

    MDR report key: 3813185 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-03957
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    December 3, 2013
    Report Date
    April 20, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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, ¿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 PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00401 / -00403 AND -03957).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, INSTABILITY, DISLOCATION AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012. ADDITIONALLY, THE PATIENT WAS REVISED (B)(6) 2013. REVIEW OF INVOICE HISTORY INDICATES THE TROCHANTER WAS REPAIRED DURING THE (B)(6) 2012 REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S OPERATIVE (OP) NOTES DATED (B)(6) 2012 REPORTS PATIENT WAS REVISED DUE TO HIP FRACTURE. DURING THE REVISION PROCEDURE, THE OP REPORT NOTES SCAR TISSUE, BLACK DEPOSITS IN THE SOFT TISSUE CONSISTENT WITH METALLOSIS, CAVITARY DEFECT, AND HETEROTROPHIC BONE WERE OBSERVED. THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL OP NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED DUE TO METALLOSIS AND FOR THE REMOVAL OF ABDUCTOR MECHANISM. OP NOTES REPORT THE PRESENCE OF BLOODY AND DARK-TINGED FLUID CONSISTENT WITH METALLOSIS AND A DEFECT IN THE MID REGION OF THE HIP ABDUCTORS. THE HEAD WAS REMOVED AND REPLACED; THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR PRODUCT. THE STEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290926 M2A-T UNIV 2-HOLE SHELL SZ 41/58 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 067540

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R