BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 8790153 · Received July 15, 2019

    Report

    Report Number
    0001825034-2019-03011
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    August 14, 2018
    Report Date
    April 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FAILED RIGHT TOTAL HIP ARTHROPLASTY, ABDUCTOR TEAR, MILD METALLOSIS, MINOR METAL DEBRIS AROUND THE ACETABULUM AND NOTED MINIMAL TRUNNIONOSIS ONE M2A-MAGNUM HEAD WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE RETURNED DEVICE HAS STAINING ON THE OUTSIDE DIAMETER ALONG WITH DEBRIS ON THE FACE. THERE IS NO VISIBLE DEBRIS INSIDE OF THE TAPER OF THE DEVICE. THE DEVICE HISTORY RECORD (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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. MEDICAL RECORDS WERE RECEIVED AND REVIEWED, HOWEVER, COMPLAINT COULD NOT BE CONFIRMED. MEDICAL RECORDS NOTED MILD METALLOSIS BUT MINIMAL FOR A METAL ON METAL HIP, MINOR METAL DEBRIS AROUND THE ACETABULUM AND MINIMAL TRUNNIONOSIS. THE ACETABULUM AND STEM WERE NOTED TO BE WELL FIXED AND BOTH WERE RETAINED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: US157850, ITEM NAME: M2A-MAGNUM CUP, LOT #: 151010; ITEM NUMBER: 139252, ITEM NAME: M2A-MAGNUM TAPER INSERT, LOT #: 003920; ITEM NUMBER: 11-103202, ITEM NAME: TAPERLOC FEMORAL STEM, LOT #: 925720. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03008, 0001825034 - 2019 - 03009, 0001825034 - 2019 - 03010. 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 HIP REVISION APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO AN ABDUCTOR TEAR. DURING THE OPERATIVE PROCEDURE METALLOSIS, METAL DEBRIS AND TRUNNIONOSIS WERE NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581509 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 651000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE