BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE 133 T1 PPS HO 15X150MM

    MDR report key: 19984206 · Received August 14, 2024

    Report

    Report Number
    0001825034-2024-02027
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 26, 2024
    Report Date
    December 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304489776
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-107170 ITEM NAME TPRLC 133 MP TYPE1 PPS HO 17.0 LOT # 7247937. 51-107170 ITEM NAME TPRLC 133 MP TYPE1 PPS HO 17.0 LOT # 6402029. 51-106150 ITEM NAME TPRLC 133 MP TYPE1 PPS SO 15.0 LOT # 6945746. G2: FOREIGN: JAPAN. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4, G3, G6, H2, H6 AND H11. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). STERILITY HAS NOT BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT THE REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONSIDERED CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND A PACKAGING DESIGN ISSUE. THE REPORTED EVENT HAS BEEN CONFIRMED BY EVALUATION OF THE RETURNED PRODUCT AND PROVIDED PHOTOS. THE DEVICE EVALUATION FOUND THE PRODUCT TO BE CONFORMING AND STERILITY NOT COMPROMISED. FURTHER, THE EVENT DID NOT CONTRIBUTE TO A SERIOUS INJURY; THEREFORE, THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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 THAT WHEN INSPECTING THE PRODUCT, IT WAS IDENTIFIED AS HAVING DAMAGED STERILE PACKAGING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151726 TAPERLOC COMPLETE 133 T1 PPS HO 15X150MM PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 7089476 00880304489776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE H11