BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 60MM

    MDR report key: 8126194 · Received December 3, 2018

    Report

    Report Number
    0001825034-2018-11022
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    May 6, 2018
    Report Date
    June 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. OP NOTES INDICATED REVISION DUE TO FAILED METAL ON METAL ION TOXICITY, PAIN, CLICKING AND SENSE OF LOOSENESS. THERE WAS UNREMITTING PAIN WITH CLICKING NOISE, SENSE OF LOOSENING, CORROBORATED ELEVATED ION LEVELS. METALLOSIS WAS ALSO PRESENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: ABX-US157866, ITEM NAME: 66OD X 60 ID MAGNUM ABX PF CUP, LOT #: 907690; ITEM NUMBER: 192515, ITEM NAME: ECHO POR FEM RED LAT NC 15X155, LOT #: 428220; ITEM NUMBER: 139270, ITEM NAME: M2A-MAGNUM 52-60MM TPR INSR +3, LOT #: 221770. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -11023. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO ELEVATED ION LEVELS, PAIN AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966424 M2A-MAGNUM MOD HD SZ 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 899620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R