BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 3941162 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06211
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    December 12, 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. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION THAT WAS REPORTED ON THE INITIAL MEDWATCH. THE COMPLAINT DESCRIPTION INCORRECTLY REPORTED THE INITIAL PROCEDURE AS A FEMORAL RESURFACING PROCEDURE, THIS SHOULD BE REPORTED AS A TOTAL HIP ARTHROPLASTY.

    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.

    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) 2009. DURING POST-OPERATIVE MONITORING, UNSPECIFIED MEDICAL COMPLICATIONS WERE NOTED ON (B)(6) 2009. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. THE PATIENT WAS REPORTED TO HAVE HAD A HEART ATTACK ON (B)(6) 2009 THAT WAS TREATED WITH A HEART CATHETER AND STENT PLACEMENT THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO 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) 2009. DURING POST-OPERATIVE MONITORING, UNSPECIFIED MEDICAL COMPLICATIONS WERE NOTED ON (B)(6) 2009. 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
    419702 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 617140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R