BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MOLDED CR-FLEX ARTICULAR SURFACE, BLUE, 10 MM

    MDR report key: 6248370 · Received January 12, 2017

    Report

    Report Number
    0001822565-2017-00169
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    September 5, 2016
    Report Date
    May 9, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE COMPLAINT COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE COMPLAINT WAS NOT CONFIRMED. NO FAILURES WERE DETECTED. 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 · 1

    SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: NEXGEN PRECOAT CR-FLEX FEMORAL SIZE G-RT, CATALOG NUMBER: 00595001702, LOT NUMBER: NI. ITEM NAME: NEXGEN PRECOAT STEMMED TIBIAL PLATE SIZE 7, CATALOG NUMBER: 00598005701, LOT NUMBER: NI.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: NEXGEN PRECOAT CR-FLEX FEMORAL SIZE G-RT, LOT NUMBER: 62987691. ITEM NAME: NEXGEN PRECOAT STEMMED TIBIAL PLATE SIZE 7, LOT NUMBER: 63092297. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2017-00174-1/00176-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN GENITOURINARY/RENAL COMPLICATION APPROXIMATELY 9 MONTHS AFTER DATE IMPLANTED. IT IS UNCERTAIN IF THE EVENT IS DEVICE RELATED. THE OUTCOME IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28688 NEXGEN MOLDED CR-FLEX ARTICULAR SURFACE, BLUE, 10 MM PROTHESIS, KNEE JWH ZIMMER, INC. NI 62942016

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R