BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR 48M

    MDR report key: 3924475 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06018
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KXA
    PMA / PMN Number
    PK021799
    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 RELATED TO THE EVENT. 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: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06018 /-06019).

    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.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2007 DUE TO A DEEP INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTION DID NOT OCCUR IN THE JOINT AREA. PATIENT DEATH OCCURRED ON (B)(6) 2010 DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DEEP INFECTION AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON AN UNKNOWN DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2007. SUBSEQUENTLY, PATIENT EXPERIENCED A DEEP INFECTION AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401665 RECAP CEMENT FMRL HD RESUR 48M PROSTHESIS, HIP KXA BIOMET ORTHOPEDICS N/A 115920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R