BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 10338260 · Received July 29, 2020

    Report

    Report Number
    0001825034-2020-02977
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    January 15, 2019
    Report Date
    September 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED : UPDATED: G4; H2; H3; H6. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS THAT WERE REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT FOR THE INSERT. A DEFINITIVE ROOT CAUSE CANNOT 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: US157858-M2A-MAGNUM PF CUP 58ODX52ID-829560. 103209-TAPERLOC POR FMRL 17.5X155-823640. 139268-M2A-MAGNUM 52-60MM TPR INS STD-532050. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02976, 0001825034-2020-02978, 0001825034-2020-02979. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. 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 THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO ALTR, SWELLING, IN-VIVO CORROSION AND IMPLANT WEAR. DURING THE PROCEDURE THE BIOMET MAGNUM SLEEVE WAS FOUND TO BE COLD FUSED TO THE TRUNNION OF THE BIOMET TAPERLOC STEM. THICKENED PSEUDOCAPSULE WAS NOTED AND LARGE EFFUSION WHICH WAS NON-PURULENT. SOME BLACK CORROSIVE MATERIAL WAS NOTED WITHIN THE SYNOVIUM CONSISTENT THE METAL-ON-METAL BEARING AND METAL WEAR DEBRIS. THE BIOMET MAGNUM FEMORAL HEAD AND SLEEVE WERE NOTED TO BE COLD FUSED TO THE TRUNNION OF THE TAPERLOC STEM. MINIMAL CORROSION WAS NOTED AFTER APPROPRIATE CLEANING OF THE TRUNNION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803862 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 220570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R