BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 13152642 · Received January 4, 2022

    Report

    Report Number
    3002806535-2022-00002
    Event Type
    Injury
    Date Received
    January 4, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ITEM AND LOT NUMBERS HAVE BEEN RECEIVED. DESIGN CONTROL IS NOW THE (B)(4). EVENT TO BE REPORTED UNDER (B)(4) MEDWATCH FACILITY. EVENT WAS PREVIOUSLY REPORTED (INITIAL AND FINAL) BY (B)(4). ADDITIONAL INFORMATION RECEIVED: PRODUCT ITEM AND LOT NUMBERS: DESC: M2A-MAGNUM RECAP CUP 54ODX48ID, ITEM: 157854, LOT: 1944139. DESC: M2A-MAGNUM MOD HD SZ 48MM, ITEM: 157448, LOT: 1789627. CONCOMITANT MEDICAL PRODUCTS ASSOCIATED PRODUCTS: MEDICAL PRODUCT: TAPERLOC BMPC 11.0X142MM, CATALOG NO.: 650-0554BM, LOT NO.: 1901177. MEDICAL PRODUCT: MAGNUM TPR ADPR TI 42-50/- 2MM, CATALOG NO.: 130829, LOT NO.: 1905275 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-00001. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SUMMARY: PRODUCT NUMBERS RECEIVED DEC 28, 2021: NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND STERILIZATION RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. NO COMPATIBILITY ISSUES WERE NOTED. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (5) SIMILAR COMPLAINTS ABOUT ITEM #157854 (INCLUDING INITIATING COMPLAINT). THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST LOT #1944139. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (3) SIMILAR COMPLAINTS ABOUT ITEM #157448 (INCLUDING INITIATING COMPLAINT). THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST LOT #1789627. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER THE INVESTIGATION OF THIS EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT NUMBERS: 3002806535-2022-00001-1. IF ANY ADDITIONAL INFORMATION IS DISCOVERED OR RECEIVED THAT MAY ADJUST ANY CONCLUSIONS OR DATA, A SUPPLEMENTAL REPORT WILL BE RENDERED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING ELEVATED METAL ION LEVELS APPROXIMATELY 10 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    REPORTED COMPLAINT: THE CLAIM FROM THE PATIENT (MALE, BORN ON (B)(6) 1969) FOR DAMAGES ALLEGEDLY CAUSED BY AN UNKNOWN BIOMET PROSTHESIS IMPLANTED AT THE LEFT HIP ON (B)(6) 2010. EXAMINATIONS RESULTED IN ELEVATED METAL IONS LEVELS. 28 DEC 2021: ADDI RECEIVED: INFORMATION ABOUT THE USED PRODUCT RECEIVED, THE COMPLAINT HAS BEEN RE-OPENED AND UPDATED, PRODUCTS INFORMATION HAS BEEN UPDATED REGARDING EMAIL AND ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512634 M2A-MAGNUM MOD HD SZ 48MM MAGNUM M2A HEADS LG DIAM KWA BIOMET UK LTD. N/A 1789627

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEEH10