BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 12438335 · Received September 8, 2021

    Report

    Report Number
    0001825034-2021-02588
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    December 19, 2019
    Report Date
    November 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. PRODUCT WAS NOT RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE COULD NOT 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 157446 ¿ M2A MAGNUM HEAD - 530580, 139252 ¿ M2A MAGNUM TAPER ¿ 506340, 192413 ¿ ECHO FEMORAL STEM ¿ 674160. PRODUCT WILL NOT BE RETURNING TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -02589.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO ALTR AND PSEUDOTUMOR. DURING THE REVISION, A SMALL DEFECT WAS NOTED BEHIND THE ACETABULAR COMPONENT BUT NO DEVICE COMPLICATIONS WERE NOTED. 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
    1338460 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 343520

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10