BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD +3MM NK

    MDR report key: 3080069 · Received April 26, 2013

    Report

    Report Number
    0001825034-2013-01171
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01171 & 03746 / 03747).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES ELEVATED METAL ION LEVELS. 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
    183211 32MM M2A MOD HEAD +3MM NK PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 434190

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R