BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX48MM CUP

    MDR report key: 8721974 · Received June 21, 2019

    Report

    Report Number
    0001825034-2019-02685
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    April 22, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL REPORT DETAILS THAT THE PATIENT TURNED WRONG AND HAS INCREASED PAIN WITH SPASMS BILATERAL TOTAL HIP PROSTHESIS¿S APPEAR WELL SEATED. OLD HEALED RIGHT PUBIC RAMUS FRACTURE. NO ACUTE FRACTURE OR DISLOCATION IDENTIFIED. CT REPORT CONFIRMS THERE IS AN AVULSION OF THE LESSER TROCHANTER ON THE POSTERIOR CORTEX OF THE PROXIMAL FEMUR. OLD HEALED PUBIC RAMUS FRACTURE. NO EVIDENCE OF DISLOCATION. METAL LEVELS WERE EXTREMELY HIGH. IMPLANTS THEMSELVES SEEMED STABLE RADIOGRAPHICALLY BACK TO 2012. THERE WAS BLACK STAINING OF THE TISSUE. A COMPLETE SYNOVECTOMY WAS DONE AND METALLOSIS REMOVED. THE ACETABULUM WAS INSPECTED AND THERE WAS NO CLINICAL EVIDENCE OF LOOSENING. THERE IS OSTEOLYSIS OF THE PROXIMAL FEMUR WITH INSUFFICIENCY FRACTURE OF THE LESSER TUBEROSITY FROM THE METALLOSIS AND OSTEOLYSIS. 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. 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

    IT WAS REPORTED, PATIENT TURNED WRONG AND EXPERIENCED SEVERE PAIN AND SPASM. CT CONFIRMED AN AVULSION OF THE LESSER TROCHANTER ON THE POSTERIOR CORTEX OF THE PROXIMAL FEMUR. FURTHER DIAGNOSTICS REVEALED EXTREMELY HIGH SERUM ION LEVELS. THE PATIENT WAS REVISED 16 YEARS POST INITIAL SURGERY FOR METALLOSIS, ELEVATED METAL ION LEVELS, DIFFICULTY AMBULATING, OSTEOLYSIS, BONE FRACTURE, AND PAIN. THERE WAS BLACK STAINING OF THE TISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: M2A 38MM MOD HD -6MM NK, # ITEM 11-173660, LOT: 934760; TAPERLOC POR FMRL LAT 10X140, # ITEM 11-103204, LOT: 191410. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02684. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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 PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY APPROXIMATELY 16 YEARS POST INITIAL SURGERY DUE TO ELEVATED METAL ION LEVELS. PATIENT STATED SHE EXPERIENCED 7 YEARS OF TROUBLE TRYING TO GAIN STRENGTH AND FRACTURED HER FEMUR 5 MONTHS PRIOR TO REVISION. FEMORAL HEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515395 M2A 38MMX48MM CUP PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 383250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R