BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD 2HL SHL

    MDR report key: 6891164 · Received September 25, 2017

    Report

    Report Number
    0001825034-2017-07333
    Event Type
    Injury
    Date Received
    September 25, 2017
    Report Date
    September 25, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BASED ON INITIAL INFORMATION AND INVESTIGATION RESULTS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-05054. 0001825034-2017-07334. EVENT DATE NOV 2016. EXPLANTED DATE NOV 2016 CONCOMITANT PRODUCTS: TI LOW PROFILE SCREW 6.5X20MM CATALOG#: 103531 LOT#: 707760. M2A TPR HI CARBON 41/32MM LNR CATALOG#: 15-105044 LOT#: 073870. 32MM M2A HI CARBON HD STD NK CATALOG#: 11-163688 LOT#: 343280. UNKNOWN STEM CATALOG#: NI LOT#: NI. THERAPY DATE NOV 2016. FOREIGN--(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PHOTOS OF THE IMPLANT HAS BEEN INSPECTED AND EXTERNAL INVESTIGATION WAS RECEIVED, WHICH DEMONSTRATED : A) A LOT OF SCRATCHES ON THE SLIDING SURFACE. NO CORROSION BUT SMALL DENT WAS OBSERVED, B) K, CA, TI, FE WAS DETECTED FROM THE BACK SIDE OF THE LINER. DESIGN HISTORY RECORDS WAS REVIEWED AND NO DISCREPANCIES WERE FOUND TO BE RELATED WITH THIS EVENT. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 8 YEARS POST PRIMARY SURGERY, DUE TO PSEUDOTUMOR. DURING THE REVISION, THE CUP, LINER AND HEAD WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670551 M2A-T M/H RAD 2HL SHL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 205770

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R