BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CEMENTED IM STEM 11X150

    MDR report key: 16977441 · Received May 22, 2023

    Report

    Report Number
    0001825034-2023-01156
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304238930
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01155, AND 0001825034-2023-01157. D10 MEDICAL DEVICES: OSS 7CM SEG ELLIPT FEMORAL RT CATALOG#: 150356 LOT#: 122370; OSS NON-MOD TIB PLATE LONG 67 CATALOG#: 150420 LOT#: 662850; OSS TIBIAL POLY BEARING 12MM CATALOG#: 150410 LOT#: 981590; OSS POLY TIBIAL BUSHING CATALOG#: 150476 LOT#: 735100; OSS POLY FEMORAL BUSHINGS CATALOG#: 150477 LOT#: 412030; OSS POLY LOCK PIN CATALOG#: 150478 LOT#: 887350; OSS AXLE CATALOG#: 150480 LOT#: 576510; OSS REINFORCED YOKE CATALOG#: 150493 LOT#: 737520. G3 FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: SUGGESTED CODE: MECHANICAL G4-STEM. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. X-RAY REVIEW INDICATES THERE IS LOOSENING AND ANGULATION OF THE FEMORAL IMPLANT OF THE RIGHT KNEE ARTHROPLASTY WITH IMPLANT SUBSIDENCE. 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

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY FOURTEEN MONTHS POST-IMPLANTATION DUE TO LOOSENING.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741250 OSS CEMENTED IM STEM 11X150 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 851740 00880304238930

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10