BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM -3

    MDR report key: 15418077 · Received September 14, 2022

    Report

    Report Number
    0001825034-2022-02124
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    July 6, 2022
    Report Date
    February 24, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: CUP: 0001825034-2022-02123, FMRL: 0001825034-2022-02125. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED IT APPEARS TO HAVE SOME TYPE OF RESIDUE ALL OVER OUTSIDE OF THE MODULAR HEAD AND IN THE TAPER AND DOES SEEM TO HAVE WEAR AND DAMAGE FROM EXTRACTION. ADDITIONALLY, THE HEAD WAS SENT FOR ADDITIONAL TESTING. THE TAPER WAS DETERMINED TO HAVE EVIDENCE OF CORROSIVE ATTACK AND ABUNDANT CORROSION DEBRIS. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02123-1. 0001825034-2022-02125-1. H6: MECHANICAL (G04) HEAD. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THERE IS A DARK DISCOLORATION PRESENT ON THE STEM AND IN THE HEAD TAPER. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO RADIOGRAPHIC OSTEOLYSIS. DURING THE PROCEDURE A PSEUDOCAPSULE, HYPERTROPHIC VILLOUS SYNOVIUM, SCAR TISSUE AND GRANULOMATOUS TISSUE WERE ALL EXCISED. IT WAS NOTED THAT CORROSIVE DEBRIS WAS FOUND ON THE TAPER, AND THE HEAD AND TAPER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746509 SELEX/MAGNUM MOD HD 40MM -3 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI 743640

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R CAT #: 14-103202 FMRL.LOT #: 018440.| CAT #: US157846 CUP.LOT #: 451630.