BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS ANCHOR PLUG 14MM

    MDR report key: 11385238 · Received February 26, 2021

    Report

    Report Number
    0001825034-2021-00580
    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
    00880304002890
    PMA / PMN Number
    K031804
    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 · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THE SHAFT OF THE ANCHOR PLUG HAS FRACTURED OFF INTO THE SPINDLE. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE FRACTURE SURFACE SHOWED EXCESSIVE SMEARING FOR THE MOST PART AND SMALL NON-SMEARED REGIONS REVEALING DUCTILE OVERLOAD DIMPLES, SUGGESTING A POSSIBILITY OF TENSILE OVERLOAD MODE OF FAILURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00579. MEDICAL DEVICES: CPS SM SPDL WITH PINS 600LBF CATALOG#: 178354 LOT#: 783190. 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

    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
    285385 CPS ANCHOR PLUG 14MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 752770 00880304002890

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R