BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM 52MM

    MDR report key: 7516308 · Received May 15, 2018

    Report

    Report Number
    0001825034-2018-03329
    Event Type
    Injury
    Date Received
    May 15, 2018
    Report Date
    August 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (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. 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

    IT WAS REPORTED THAT APPROXIMATELY 10 YEARS POST IMPLANTATION A PATIENT IS EXPERIENCING PAIN, ELEVATED ION LEVELS, AND A CLICKING SOUND. DURING A MEDICAL EXAM, THE PATIENT IDENTIFIED THE PAIN AS A 1 OUT OF 10 WITH ACHING AND CLICKING. THE SYMPTOMS WERE OF A GRADUAL ONSET OVER A PERIOD OF MONTHS. THE SYMPTOMS TEND TO BE INTERMITTENT, AND ARE AGGRAVATED BY PROLONGED STANDING. A PHYSICAL EXAMINATION PRESENTED NO TENDERNESS, BUT DID EXHIBIT MILD CLUNKING WITH LUMBAR AND HIP EXTENSION. IT WAS DIFFICULT TO DISTINGUISH FROM SOFT TISSUE SNAPPING. ABLE TO PERFORM FULL RANGE OF MOTION WITH NO PAIN OR SIGNS ON INTERNAL/EXTERNAL IMPINGEMENT. JOINTS APPEARED STABLE. MUSCLE STRENGTH IS SUPERIOR. THE RIGHT LOWER EXTREMITY APPEARS TO BE APPROXIMATELY 1 TO 2 CM SHORTER THAN THE LEFT. THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. MEDICAL DEVICES: ITEM # 11-103206, FEMORAL STEM, LOT # 175100, ITEM # 139270, TAPER INSERT, LOT # 172460, ITEM # US157858, CUP, LOT # 590680. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03329, 0001825034-2018-03330.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST RIGHT TOTAL HIP REPLACEMENT A PATIENT IS EXPERIENCING PAIN, DISCOMFORT, LACK OF MOBILITY, METAL WEAR, METAL POISONING, ELEVATED METAL IONS, AND LIMITATION OF DAILY ACTIVITIES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355991 M2A-MAGNUM MOD HD SZ 52MM 52MM HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 933620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R