BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 3943656 · Received July 18, 2014

    Report

    Report Number
    0001825034-2014-06221
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    November 6, 2008
    Report Date
    November 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062995
    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:

    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 CORRECTED INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED DATA: 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE OF THE FEMORAL NECK AND/OR POSTOPERATIVE PAIN."

    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, INTERTROCHANTERIC FRACTURE WAS NOTED ON (B)(6) 2010. 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. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE AND FURTHER SUGGESTS PATIENT UNDERWENT AN ADDITIONAL FEMORAL RESURFACING PROCEDURE FOR AN UNKNOWN SIDE ON (B)(6) 2008. ADDITIONALLY, INVOICE HISTORY SUGGESTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 WHERE THE ACETABULAR CUP WAS REMOVED AND REPLACED.

    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 AND TESTING, AN INTERTROCHANTERIC FRACTURE THAT WAS NOTED ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE WHERE A ROD WAS IMPLANTED TO REPAIR THE FRACTURE. A REVIEW OF INVOICE HISTORY SUGGESTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 WHERE THE ACETABULAR CUP WAS REMOVED AND REPLACED.

    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 AND TESTING, AN INTERTROCHANTERIC FRACTURE WAS NOTED. SUBSEQUENTLY, PATIENT UNDERWENT A REOPERATION ON (B)(6) 2010 WHEREBY A ROD WAS IMPLANTED TO REPAIR THE FRACTURE.

    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, THE PATIENT EXPERIENCED AN INTERTROCHANTERIC FRACTURE THAT WAS NOTED ON (B)(6) 2010. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE AND FURTHER SUGGESTS PATIENT UNDERWENT AN ADDITIONAL FEMORAL RESURFACING PROCEDURE FOR AN UNKNOWN SIDE ON (B)(6) 2008. ADDITIONALLY, INVOICE HISTORY SUGGESTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2008 WHERE THE ACETABULAR CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421524 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 928760

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R