BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 MP SP T1 PPS HO 5X95

    MDR report key: 21018193 · Received December 26, 2024

    Report

    Report Number
    0001825034-2024-03041
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    July 26, 2024
    Report Date
    December 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K110400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-102050, TPRLC XR FP TYPE1 PPS 5X130MM, 3947625; 51-104120, TPRLC 133 T1 PPS HO 12X144MM, 7057072; 51-105100, TPRLC XR T1 PPS 10X140MM, 7206029; 51-100060, TPRLC 133 FP TYPE1 PPS SO 6.0, 6994327. G2: FOREIGN: JAPAN. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE POUCH WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625667 TLOC 133 MP SP T1 PPS HO 5X95 PROSTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 6934285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown