BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 60ODX54ID

    MDR report key: 3913743 · Received July 3, 2014

    Report

    Report Number
    0001825034-2014-05938
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    August 8, 2008
    Report Date
    October 18, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON THE INITIAL REPORT. CORRECT REVISION / EXPLANT DATE IS (B)(6) 2008. EVENT DESCRIPTION ¿ PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: 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

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005. SUBSEQUENTLY, PATIENT EXPERIENCED PSOAS TENDONITIS AND UNDERWENT ACETABULAR REVISION ON (B)(6) 2008.

    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) 2005. SUBSEQUENTLY, PATIENT EXPERIENCED PSOAS TENDONITIS AND UNDERWENT ACETABULAR REVISION ON (B)(6) 2008.

    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) 2005. SUBSEQUENTLY, PATIENT EXPERIENCED PSOAS TENDONITIS AND UNDERWENT ACETABULAR REVISION ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389419 M2A-MAGNUM PF CUP 60ODX54ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 347150

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R