BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 MP SP T1 PPSHO 6X97.5

    MDR report key: 21739681 · Received April 1, 2025

    Report

    Report Number
    0001825034-2025-00933
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 7, 2025
    Report Date
    June 26, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304512993
    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: 51-104110; ITEM NAME TPRLC 133 T1 PPS HO 11X142MM LOT # 6636408. 51-145150; ITEM NAME TPRLC XR MP T1 PPS 15X115MM LOT # 6041831. 51-107170; ITEM NAME TPRLC 133 MP TYPE1 PPS HO 17.0 LOT # 7269926. 51-100040; ITEM NAME TPRLC 133 FP TYPE1 PPS SO 4.0 LOT # 7247907. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; D9; G3; H2; H3; H6; H10. PRODUCT RETURNED AND EVALUATED. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (POUCH). STERILITY HAD BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE INSPECTING THE PACKAGING, IT WAS FOUND WITH INNER PACKAGE WAS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010747 TLOC 133 MP SP T1 PPSHO 6X97.5 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7183064 00880304512993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown