BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR MP FP T1 PPS 5X95MM

    MDR report key: 21526240 · Received March 5, 2025

    Report

    Report Number
    0001825034-2025-00554
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 10, 2025
    Report Date
    June 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304517424
    PMA / PMN Number
    K120030
    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 {UPDATE/CORRECTED}. UPDATED: D9; G3; H2; H3; H6. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (POUCH). STERILITY HAS 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. 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 # 7193497; 51-105140, ITEM NAME TPRLC XR T1 PPS 14X148MM, LOT # 7275311; 51-100040, ITEM NAME TPRLC 133 FP TYPE1 PPS SO 4.0, LOT # 3570571. G2: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN INSPECTING CIRCULATED ITEMS, THE INNER POUCH WAS FOUND DAMAGED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275968 TPRLC XR MP FP T1 PPS 5X95MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 7155841 00880304517424

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown