BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS/OSS 5CM TPR ADAPT W/OSS SC

    MDR report key: 19098058 · Received April 12, 2024

    Report

    Report Number
    0001825034-2024-01013
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 18, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304430792
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), D10 MEDICAL DEVICES: COMPRESS CENTERING SLEEVE 14MM CATALOG#: 178536 LOT#: 396780. COMPRESS SHORT ANCHOR PLUG 12MM CATALOG#: 178554 LOT#: 201390. COMPRESS TRANSVERSE PIN 6PK 32MM CATALOG#: 178527 LOT#: 501730. COMPRESS SHORT ANCHOR PLUG 12MM CATALOG#: 178554 LOT#: 65889607. COMPRESS TRANSVERSE PIN 6PK 36MM CATALOG#: 178528 LOT#: 562900. COMPRESS XS SHT SPDL W PINS 800LBF CATALOG#: 178364 LOT#: 625580. COMPRESS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 65753467. OSS RS AXLE CATALOG#: 161035 LOT#: 65816757. OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 299680. OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 65985059. OSS POLY LOCK PIN CATALOG#: 150478 LOT#: 65734013. OSS RS POLY FEM BUSHINGS SET/2 CATALOG#: 161034 LOT#: 65795550. OSS RS 12MM LS TIBIAL BEARING CATALOG#: 161094 LOT#: 66043842. OSS POR STRAIGHT STEM 10.5X150 CATALOG#: 150448 LOT#: 905350. OSS MOD TIB BASEPLATE 67MM CATALOG#: 150421 LOT#: 65922750. OSS SEGMENTAL STACKING ADAPTER CATALOG#: 150483 LOT#: 65904622. OSS 5CM DIAPHYSEAL SEGMENT CATALOG#: 150465 LOT#: 705810. OSS RS 7 CM MOD SEG FMRL-RT CATALOG#: 161011 LOT#: 612060. TIBIAL PERIMETER CONE RIGHT SIZE LARGE CATALOG#: 42545001523 LOT#: 64627887. TIBIAL CENTRAL CONE SIZE LARGE CATALOG#: 42545000513 LOT#: 65076064. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REPORTED UNDER 0001825034-2024-01007.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO AN UNKNOWN FAILURE OF THE COMPRESS PROSTHESIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REPORTED UNDER 0001825034-2024-01007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509976 COMPRESS/OSS 5CM TPR ADAPT W/OSS SC PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 65766806 00880304430792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.