BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM COM

    MDR report key: 9595553 · Received January 16, 2020

    Report

    Report Number
    0001825034-2020-00265
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    April 15, 2019
    Report Date
    August 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION - 4114 DOES NOT APPLY AS PRODUCT WAS RETURNED. PLEASE REMOVE. INSPECTION OF THE RETURNED DEVICE REVEALED. A M2A-MAGNUM MOD HD SZ 50MM COM, PART # 157450 FROM LOT 908990, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE HEAD TO REMAIN ASSEMBLED WITH THE TAPER INSERT. THE OUTER RADIUS OF THE HEAD IS SCUFFED AND SCRATCHED. A M2A-MAGNUM RECAP CUP 56ODX50ID, PART # US157856 FROM LOT 242110, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND A GOUGE IN THE INNER RADIUS ALONG WITH VARIOUS SCRATCHING. DEBRIS REMAINS AFFIXED TO THE POROUS COATING. THE ETCHING ON THE TAPER WAS CONFIRMED TO BE -6. SCRATCHING WAS OBSERVED INSIDE THE TAPER AND AROUND THE CIRCULAR CUT OUTS OF THE INSERT. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6 CORRECTED D4; H4 REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS IDENTIFIED AN INITIAL SURGERY (B)(6) 2006 AND A REVISION SURGERY ON (B)(6) 2019 AS PATIENT WAS PRESENTED WITH PAIN, ELEVATED METAL LEVELS, EXTENSIVE OSTEOLYSIS ON X-RAY, AND MASSIVE DESTRUCTION OF PELVIS ON CT. UPON ENTRY, BLACK TISSUE AND BLACK METALLOSIS WAS NOTED AS WELL AS A PSEUDOTUMOR. THE CUP WAS NOTED TO BE STABLE DESPITE MASSIVE BONE LOSS IN THE PELVIS. LARGE HOLES NOTED IN PELVIS CONTAINING BLACK TOOTHPASTE LIKE MATERIAL. SIGNIFICANT OSTEOLYSIS NOTED AROUND PROXIMAL FEMUR. CUP WAS REMOVED WITH EXPLANT DEVICE; HEAD AND TAPER ADAPTER WERE EXPLANTED AS WELL. STEM WAS LEFT INTACT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT 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 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR 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. CONCOMITANT MEDICAL PRODUCTS: ITEM# US157856/M2A CUP/ LOT # 242110, ITEM # 103208/ TAPERLOCK STEM /LOT # 721530, ITEM# 139252/ TAPER INSERT/ LOT# 118160. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -00266, 0001825034 -2020 -00267, 0001825034 -2020 -00268.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT HIP REVISION SURGERY APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED METAL ION LEVELS. DURING THE REVISION PROCEDURE METALLOSIS, BONE LOSS AND A PSEUDOTUMOR 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
    59903 M2A-MAGNUM MOD HD SZ 50MM COM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 908990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10