BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM -6

    MDR report key: 4192496 · Received October 22, 2014

    Report

    Report Number
    0001825034-2014-08187
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    December 16, 2010
    Report Date
    December 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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. 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 NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06249, -08187, -08248).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON A PREVIOUS MEDWATCH. UPON REVIEW OF COMPLAINT, IT WAS NOTED THAT THIS PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 RATHER THAN A HIP RESURFACING PROCEDURE AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT EXPERIENCED UNSPECIFIED SURGICAL COMPLICATIONS NOTED ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTS THAT ON AN UNKNOWN DATE SEVERAL YEARS AGO, PATIENT WAS REVISED DUE TO PAIN IN WHICH THE HEAD WAS REPLACED AND SOME TROCHANTERIC BONE WAS REMOVED IN CASE IMPINGEMENT WAS THE PROBLEM. PATIENT IS CURRENTLY ALLEGING COBALT POISONING AND REQUESTING A REVISION. REVIEW OF INVOICE HISTORY INDICATES CONFIRMS THE INITIAL PROCEDURE DATE AND SHOWS THE HEAD WAS REMOVED AND REPLACED (B)(6) 2010. NO FURTHER PROCEDURE WAS LOCATED IN THE INVOICE RECORD.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT EXPERIENCED UNSPECIFIED SURGICAL COMPLICATIONS NOTED ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTS THAT ON AN UNKNOWN DATE SEVERAL YEARS AGO, PATIENT WAS REVISED DUE TO PAIN IN WHICH THE HEAD WAS REPLACED AND SOME TROCHANTERIC BONE WAS REMOVED IN CASE IMPINGEMENT WAS THE PROBLEM. PATIENT IS CURRENTLY ALLEGING COBALT POISONING AND REQUESTING A REVISION. REVIEW OF INVOICE HISTORY INDICATES CONFIRMS THE INITIAL PROCEDURE DATE AND SHOWS THE HEAD WAS REMOVED AND REPLACED (B)(6) 2010. NO FURTHER PROCEDURE WAS LOCATED IN THE INVOICE RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671585 SELEX/MAGNUM MODULAR HEAD 40MM -6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 225950

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R