BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN DISTAL FEMORAL AUGMENTS

    MDR report key: 7335351 · Received March 13, 2018

    Report

    Report Number
    0001822565-2018-01481
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 21, 2017
    Report Date
    April 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK946150
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: NEXGEN LCCK ARTICULAR SURFACE CATALOG # 00599403210 LOT # 62841440; NEXGEN LCCK FEMORAL COMPONENT CATALOG # 00599401692 LOT # 62941772; NEXGEN ALL POLY PATELLA CATALOG # 00597206529 LOT # 62913325; NEXGEN TIBIAL COMPONENT CATALOG # 00598003701 LOT # 63064339; NEXGEN PRE FEM AUGMENTS CATALOG # 00-5990-036-01 LOT # 62998830; NEXGEN AUGMENTS DISTAL ONLY FEMORAL CATALOG # 00599003621 LOT # 62591559; NEXGEN STEM EXTENSION CATALOG # 00598801012 LOT # 62937550; NEXGEN STEMS EXTENSION CATALOG # 00598801010 LOT # 62860982; NEXGEN TIBIAL BLOCK AND SCREWS CATALOG # 00598800327 LOT # 62925302; NEXGEN TIBIAL BLOCK AND SCREWS CATALOG # 00598800327 LOT # 62641746. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2018-01323, 0001822565-2018-01465, 0002648920-2018-00186, 0002648920-2018-00187, 0002648920-2018-00188, 0001822565-2018-01476, 0002648920-2018-00189, 0002648920-2018-00190, 0001822565-2018-01483, 0001822565-2018-01484.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FIRST REVISION KNEE ARTHROPLASTY DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176478 NEXGEN DISTAL FEMORAL AUGMENTS PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 62998879

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R