BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 7882428 · Received September 17, 2018

    Report

    Report Number
    0001825034-2018-08769
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    March 20, 2017
    Report Date
    December 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED A M2A-MAGNUM MOD HD SZ 42MM, PART # 157442 FROM LOT 200260, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE HEAD TO BE ASSEMBLED WITH THE TAPER INSERT UPON RECEIPT. SCUFFING AND SCRATCHING WAS FOUND ON THE OUTER RADIUS CONSISTENT WITH METAL ON METAL CONSTRUCTION. NO MAJOR DAMAGE WAS OBSERVED. A M2A-MAGNUM 42-50MM TPR INSRT-6, PART # 139252 FROM LOT 407140, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE INSERT REMAINS ASSEMBLED WITH THE HEAD UPON RECEIPT. LIGHT SCRATCHING WAS OBSERVED AROUND THE RIM OF THE TAPER AND ETCHING. AN UNIDENTIFIABLE WHITE DEBRIS WAS FOUND INSIDE THE TAPER OF THE INSERT. A M2A-MAGNUM PF CUP 48ODX42ID, PART # US157848 FROM LOT 926780, WAS ALSO RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE INNER RADIUS OF THE CUP IS SCUFFED AND WORN CONSISTENT WITH METAL ON METAL CONSTRUCTION. ONE OF THE FINS ON THE OUTER RADIUS IS CHIPPED. BONE CEMENT AND FOREIGN DEBRIS ARE STILL AFFIXED TO THE POROUS COATING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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). ITEM# US157848 M2A-MAGNUM PF CUP 48ODX42ID LOT# 926780; ITEM# 11-104112 MLRY-HD POR FMRL 12X165MM LOT# 787550; ITEM# 139252 M2A-MAGNUM 42-50MM TPR INSRT-6 LOT# 407140. 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08771; 0001825034 - 2018 - 08770; 0001825034 - 2018 - 08768.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 5 YEARS AGO. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POST OP DUE TO PAIN. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723782 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 200260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R