BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD

    MDR report key: 8789155 · Received July 15, 2019

    Report

    Report Number
    0001825034-2019-02988
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    December 11, 2018
    Report Date
    October 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03986.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING ELEVATED METAL ION LEVELS ALONG WITH AVAL RESPONSE NOTED ON AN MRI. METALLOSIS WAS FOUND IN SURROUNDING TISSUE AND INSIDE THE CAPSULE. EXTENSIVE HETEROTOPIC OSSIFICATION IS NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTED TO PHYSICIAN APPROXIMATELY 9 YEARS POST IMPLANTATION REPORTING PAIN IN RIGHT THIGH SINCE BUMPING INTO AN OBJECT. PATIENT RETURNED TO PHYSICIAN APPROXIMATELY 1 MONTH LATER WITH SYMPTOMS COMPATIBLE WITH SCIATICA. AN MRI WAS TAKEN SHOWING STENOSIS L4-L5. APPROXIMATELY 1 MONTH LATER, PATIENT UNDERWENT A REVISION DUE TO ELEVATED METAL ION LEVELS, PAIN, METALLOSIS, HETEROTOPIC OSSIFICATION AND PERIPROSTHETIC FRACTURE OF THE GREATER TROCHANTER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: M2A-MAGNUM PF CUP, # ITEM 157444, LOT 929530; M2A-MAGNUM TPR INSRT, # ITEM 139254, LOT 163800; MLRY-HD LAT POR FMRL, # ITEM 11-104213, LOT 061520. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02989. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 THAT THE PATIENT UNDERWENT REVISION DUE TO ELEVATED METAL ION LEVELS, METALLOSIS AND HETEROTOPIC OSSIFICATION APPROXIMATELY 11 YEARS POST INITIAL SURGERY. THE PREOPERATIVE DIAGNOSIS NOTED A FAILED METAL-ON-METAL RIGHT TOTAL HIP ARTHROPLASTY. DURING THE PROCEDURE, THE OPERATING SURGEON NOTED FRAGMENTATION OF THE ANTERIOR LATERAL PART OF THE GREATER TROCHANTER IN ONE LARGE PIECE, AND THERE WAS EXTENSIVE HETEROTOPIC OSSIFICATION, EXTENSIVE METALLOSIS SEEN INSIDE THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582747 M2A-MAGNUM MOD HD PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 001020 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R