BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 3941569 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06272
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    October 16, 2008
    Report Date
    November 24, 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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CORRECTION: PATIENT SEX HAS BEEN CORRECTED IN THIS REPORT DEVICE PRODUCT CODE HAS BEEN CORRECTED IN THIS REPORT THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06272 AND -08185).

    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

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT 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

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2008. DURING POST-OPERATIVE MONITORING, LOOSENING OF THE ACETABULAR CUP WAS NOTED ON (B)(6) 2008. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.

    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) 2008. DURING POST-OPERATIVE MONITORING, LOOSENING OF THE ACETABULAR CUP WAS NOTED ON (B)(6) 2008. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT WAS REVISED (B)(6) 2008 DUE TO ACETABULAR LOOSENING. BOTH THE ACETABULAR AND THE FEMORAL COMPONENTS WERE REVISED ON THAT DATE, ALTHOUGH THERE WERE NO INDICATIONS OF FEMORAL LOOSENING. REVIEW OF INVOICE HISTORY INDICATES THE MODULAR HEAD WAS REMOVED AND REPLACED ON OR ABOUT (B)(6) 2008 FOR UNKNOWN REASONS. INVOICE HISTORY ALSO SHOWS AN ADDITIONAL HIP PROCEDURE OCCURRED ON OR ABOUT (B)(6) 2009; HOWEVER, IT COULD NOT BE DETERMINED IF THIS WAS A REVISION PROCEDURE FOR THE RIGHT HIP OR AN INITIAL IMPLANT FOR THE LEFT SIDE.

    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) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2008 DUE TO ACETABULAR LOOSENING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL HIP SYSTEM.

    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) 2008. DURING POST-OPERATIVE MONITORING, LOOSENING OF THE ACETABULAR CUP WAS NOTED ON (B)(6) 2008. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419503 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 331690

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R