BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT

    MDR report key: 7742467 · Received August 2, 2018

    Report

    Report Number
    0002648920-2018-00605
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    June 29, 2018
    Report Date
    May 16, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MBH
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS NOT EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PER PACKAGE INSERT 87-6204-022-23 REV A PERSONA THE PERSONALIZED KNEE SYSTEM: INSTABILITY IS A KNOWN ADVERSE EFFECT OF THIS PROCEDURE. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 04144 - 1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: HEADLESS TROCAR DRILL PIN 3.2 MM, PART#: 00590102000, LOT#: 63808092. 2.5 MM FEMALE HEX SCREW 25 MM, PART#: 42509902525, LOT#: 63823777. TIBIA CEMENTED 5 DEGREE STEMMED, PART#: 42532008302, LOT#: 63610235. HEADLESS TROCAR DRILL PIN 3.2 MM, PART#: 00590102000, LOT#: 63808092. ALL-POLY PATELLA CEMENTED 38 MM, PART#: 42540200038, LOT#: 63633017. FEMUR TRABECULAR METAL CRUCIATE RETAINING, PART#: 42502807002, LOT#: 63631685. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO EU REGULATIONS. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION 4 MONTHS POST-IMPLANTATION DUE TO INSTABILITY WHERE THE BEARING WAS REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585841 ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER MANUFACTURING B.V. N/A 63020863

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R