BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS NON-MODULAR LONG TIBIAL BASEPLATE

    MDR report key: 7934076 · Received October 4, 2018

    Report

    Report Number
    0001825034-2018-09418
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS SEGMENTAL FEMORAL COMPONENT CATALOG # 150355 LOT # 267280, OSS TIBIAL BEARING CATALOG # 150411 LOT # 312720, OSS FEMORAL BUSHINGS SET CATALOG # 150477 LOT # 040920, OSS FEMORAL BUSHINGS SET CATALOG # 150477 LOT # 918980, OSS YOKE CATALOG # 150493 LOT # 991160, OSS TIBIAL BUSHING CATALOG # 150476 LOT # 581390, COMPRESS DEVICE SEGMENTAL ANCHOR PLUG CATALOG # 178402 LOT # 930680, COMPRESS TRANSVERSE PIN CATALOG # 178527 LOT # 785050, COMPRESS ANTI-ROTATION SPINDLE CATALOG # 178354 LOT # 925600, COMPRESS NUT CATALOG # 178512 LOT # 885860, COMPRESS CENTERING SLEEVE CATALOG # 178537 LOT # UNKNOWN, OSS DIAPHYSEAL LOCKING SCREW SET CATALOG # 150481 LOT # 133790, COMPRESS TAPER ADAPTER CATALOG # 178711 LOT # 755330, OSS DIAPHYSEAL STACKING ADAPTOR CATALOG # 150483 LOT # 975100, OSS DIAPHYSEAL SEGMENT CATALOG # 150465 LOT # 414310, OSS DIAPHYSEAL SEGMENT CATALOG # 150464 LOT # 556640, OSS AXLE CATALOG # 150480 LOT # 584290, OSS LOCKING PIN CATALOG # 150478 LOT # 210660. 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: 0001825034-2018-09174, 0001825034-2018-09175, 0001825034-2018-09178, 0001825034-2018-09181, 0001825034-2018-09183, 0001825034-2018-09420, 0001825034-2018-09421, 0001825034-2018-09422, 0001825034-2018-09423, 0001825034-2018-09424, 0001825034-2018-09425, 0001825034-2018-09426, 0001825034-2018-09428, 0001825034-2018-09429, 0001825034-2018-09430, 0001825034-2018-09433.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PATIENT UNDERWENT A KNEE ARTHROPLASTY WITH A LIMB SALVAGE SYSTEM THE PATIENT WENT INTO DEEP FLEXION, AGAINST THE SURGEONS ORDERS, AND HEARD AN AUDIBLE POPPING NOISE. THE PATIENT UNDERWENT A REVISION, DURING WHICH IT WAS REPORTED THAT THE COMPRESS NUT WAS RE-TIGHTENED AND THE CONSTRUCT WAS RE-ASSEMBLED USING THE SAME METAL COMPONENTS WITH NEW POLYETHYLENE COMPONENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775033 OSS NON-MODULAR LONG TIBIAL BASEPLATE KNEE PROSTHESIS KRO ZIMMER BIOMET, INC. N/A 068050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R