BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT OPTION SIZE F RIGHT

    MDR report key: 7131167 · Received December 19, 2017

    Report

    Report Number
    3007963827-2017-00290
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    NJL
    PMA / PMN Number
    PP060037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). UDI : (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52 SUFFIX FEMORALS SIZE EF 10 MM HEIGHT, CATALOG # 00596204010, LOT # 63326864. UNKNOWN TIBIA, CATALOG#: NI, LOT#: NI. UNKNOWN PATELLA, CATALOG#: NI, LOT#: NI. P060037/S048. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PER THE PACKAGE INSERT, PAIN AND INSTABILITY ARE LISTED AS KNOWN POTENTIAL ADVERSE EFFECTS OF THE TKA PROCEDURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2017-08616.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION DUE TO PAIN AND INSTABILITY APPROXIMATELY 15 MONTHS SUBSEQUENTLY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911290 FEMORAL COMPONENT OPTION SIZE F RIGHT PROSTHESIS, KNEE NJL ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63113864

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R