BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58ODX52ID

    MDR report key: 7014638 · Received November 9, 2017

    Report

    Report Number
    0001825034-2017-09710
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    December 12, 2017
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PART: 157452 NAME: M2A-MAGNUM MOD HD SZ 52MM LOT:708330; PART: 139268 NAME" M2A-MAGNUM 52-60MM TPR INS STD LOT: 220840.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 09709. 0001825034 - 2017 - 09710. CONCOMITANT PRODUCTS: FEMORAL STEM, UNKNOWN PART/LOT, UNKNOWN TAPER, UNKNOWN PART/LOT, FEMORAL HEAD, UNKNOWN PART/LOT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. REVISION OP NOTES CONFIRM PAINFUL METAL ON METAL HIP REVISION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT HIP REVISION DUE TO PAIN. IT WAS NOTED THAT THERE WERE SIGNS OF RADIOLUCENCY ON THE SHELL AND THE PATIENT HAD A HISTORY OF HAVING LIMITED RANGE OF MOTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AND LIMITED RANGE OF MOTION AND IS BEING CONSIDERED FOR REVISION. X-RAYS SHOW LOOSENING OF THE CUP AND BONE DETERIORATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794672 M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 561020

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SEE H10 NARRATIVE