BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 8208091 · Received January 2, 2019

    Report

    Report Number
    0001825034-2018-11389
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    September 18, 2017
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K833175
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES WHICH INDICATED PATIENT WAS REVISED WITH ELEVATED COBALT AND CHROMIUM IONS WITH MILD SYMPTOMS AND PSEUDOTUMOR. PSEUDOTUMOR FILLED WITH CLEAR YELLOW FLUID BETWEEN DEEP FASCIA AND ABDUCTOR; INTERIOR CAPSULE LINING SLIMY AND GREENISH YELLOW. PSEUDOCAPSULE PROPAGATED THROUGH, ENCOMPASSED, AND REPLACED POSTERIOR REPAIR; REMAINING POSTERIOR CAPSULE REPAIRED WITH TICRON SUTURES THROUGH BONY TUNNELS. DEVICE HISTORY RECORD (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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# US157850 M2A-MAGNUM PF CUP 50ODX44ID LOT# 640250, ITEM# 192414 ECHO POR FMRL RED NC 14X150MM LOT# 660950, ITEM# 139252 M2A-MAGNUM 42-50MM TPR INSRT-6 LOT# 789490. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2018 - 11388.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE 7 YEARS POST INITIAL HIP ARTHROPLASTY DUE TO ALTR, PSEUDOTUMOR AND ELEVATED ION LEVELS. REVISION OP NOTES NOTED :PSEUDOTUMOR FILLED WITH CLEAR YELLOW FLUID BETWEEN DEEP FASCIA AND ABDUCTOR; INTERIOR CAPSULE LINING SLIMY AND GREENISH YELLOW; NO POSTERIOR REPAIR REMAINING; PERMANENT SUTURE NOTED ON LATERAL SURFACE OF TROCHANTER INDICATIVE OF PRIOR REPAIR PSEUDOCAPSULE PROPAGATED THROUGH, ENCOMPASSED, AND REPLACED POSTERIOR REPAIR; REMAINING POSTERIOR CAPSULE REPAIRED WITH TICRON SUTURES THROUGH BONY TUNNELS; TRUNNION FREE OF CORROSION; FEMORAL STEM & ACETABULUM WELL FIXED ACETABULAR BONE SLIGHTLY OSTEOPOROTIC ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 944930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R