BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SM SPDL WITH PINS 600LBF

    MDR report key: 11385203 · Received February 26, 2021

    Report

    Report Number
    0001825034-2021-00579
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304509078
    PMA / PMN Number
    K101475
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00580. MEDICAL DEVICES: CPS ANCHOR PLUG 14MM CATALOG#:178404 LOT#: 752770; OSS POROUS IM STEM 14.5 X 90 CATALOG#: 150385 LOT#: 216820; OSS MOD TIB BASEPLATE 75MM CATALOG#: 150423 LOT#: 965060; SERIES A PAT THN 34 3 PEG CATALOG#: 184786 LOT#: 884720; OSS 3CM DIAPHYSEL SEGMENT CATALOG#: 150464 LOT#: 345070; OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 059680; OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 901970; OSS POLY LOCK PIN CATALOG#: 150478 LOT#: 923030; OSS POLY FEMORAL BUSHINGS CATALOG#:150477 LOT#: 096440; OSS AXLE CATALOG#: 150480 LOT#: 901580; OSS 11CM DIAPHYSEAL SEGMENT CATALOG#: 150468 LOT#: 795660; OSS 7CM SEGMENTAL FEMORAL LT CATALOG#: 150355 LOT#: 640610; OSS TIBIAL POLY BEARING 12MM CATALOG#:150410 LOT#: 111190; SERIES A PAT STD 34 3 PEG CATALOG#: 184766 LOT#: 764470; CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711 LOT#: 549930; CPS TRANSVERSE PIN 6PK 40MM CATALOG#: 178529 LOT#: 205550; CPS CENTERING SLEEVE 18MM CATALOG#: 178540 LOT#: 665430; CPS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 987740. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284362 CPS SM SPDL WITH PINS 600LBF PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 783190 00880304509078

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R