BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR MP T1 PPS 16X117MM

    MDR report key: 17995831 · Received October 24, 2023

    Report

    Report Number
    0001825034-2023-02477
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 5, 2023
    Report Date
    January 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304517356
    PMA / PMN Number
    K120030
    Removal / Correction Number
    N/A
    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 AND/OR CORRECTED INFORMATION. UPDATED: D9, G3, G6, H2, H3, H6 VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). STERILITY HAS NOT BEEN COMPROMISED. THE REPORTED EVENT HAS BEEN CONFIRMED BY EVALUATION OF THE RETURNED PRODUCT AND PROVIDED PHOTOS. 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-100040 TPRLC 133 FP TYPE1 PPS SO 4.0 6644495, 51-105130 TPRLC XR T1 PPS 13X146MM 6883665. G2: FOREIGN: JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02476, 0001825034-2023-02478. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING CIRCULATION THAT THE STERILE PACKAGE OF THE PRODUCTS WAS DAMAGED. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744249 TPRLC XR MP T1 PPS 16X117MM PROTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 6541707 00880304517356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE.