BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 52MM

    MDR report key: 5513499 · Received March 21, 2016

    Report

    Report Number
    0001825034-2016-00934
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    April 12, 2015
    Report Date
    April 25, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 5 OF 5 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00556-1 / 00557-1 / 00558-1 / 00933 / 00934). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2015 DUE TO PAIN AND ELEVATED METAL IONS. THE HEAD WAS REMOVED AND REPLACED AND A POLY BEARING WAS IMPLANTED. AFTER THE REVISION PROCEDURE, PATIENT ALLEGEDLY EXPERIENCED A DISLOCATION AND UNDERWENT AN OPEN REDUCTION PROCEDURE ON OR ABOUT (B)(6) 2015. PATIENT HAS ALLEGEDLY DEVELOPED AN INFECTION AND IS EXPERIENCING DIFFICULTY WALKING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORTS NOTED THAT PATIENT UNDERWENT THE REVISION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION AND FRACTURE OF THE TROCHANTER CAUSED BY PATIENT FALL. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2015 DUE TO A PHYSICAL THERAPY INJURY RESULTING IN DISLOCATION AND FRACTURED GREATER TROCHANTER. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2015 DUE TO INFECTION AND DIFFICULTLY WALKING. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED, AND CEMENT SPACERS WERE USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2015 DUE TO PAIN AND ELEVATED METAL IONS. THE HEAD WAS REMOVED AND REPLACED AND A POLY BEARING WAS IMPLANTED. AFTER THE REVISION PROCEDURE, PATIENT ALLEGEDLY EXPERIENCED A DISLOCATION AND UNDERWENT AN OPEN REDUCTION PROCEDURE ON OR ABOUT (B)(6) 2015. PATIENT HAS ALLEGEDLY DEVELOPED AN INFECTION AND IS EXPERIENCING DIFFICULTY WALKING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORTS NOTED THAT PATIENT UNDERWENT THE REVISION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION AND FRACTURE OF THE TROCHANTER CAUSED BY PATIENT FALL. DURING THE PROCEDURE, FOREIGN BODY REACTION TISSUE AND METAL DEBRIS WERE NOTED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2015 DUE TO A PHYSICAL THERAPY INJURY RESULTING IN DISLOCATION AND FRACTURED GREATER TROCHANTER. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2015 DUE TO INFECTION AND DIFFICULTLY WALKING. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED, AND CEMENT SPACERS WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169736 M2A-38 CUP NON FLARED SZ 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 456030

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R