BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 16.0

    MDR report key: 21272807 · Received January 30, 2025

    Report

    Report Number
    0001825034-2025-00229
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 10, 2025
    Report Date
    May 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304514393
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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 H11. 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. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS CONFIRMED THAT STERILITY WAS NOT BREACHED. 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-104140 ITEM NAME TPRLC 133 T1 PPS HO 14X148MM LOT # 7142515 51-104140 ITEM NAME TPRLC 133 T1 PPS HO 14X148MM LOT # 7142515 51-103160 ITEM NAME TPRLC 133 T1 PPS SO 16X152MM LOT # 6170598 G2: FOREIGN: JAPAN 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

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681910 TPRLC 133 MP TYPE1 PPS SO 16.0 PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. 7208572 00880304514393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown