BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR FP TYPE1 PPS 7X134MM

    MDR report key: 21930973 · Received April 29, 2025

    Report

    Report Number
    0001825034-2025-01249
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 7, 2025
    Report Date
    August 7, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304516908
    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 UPDATED: B4;D9;G3;H2;H3;H6. PRODUCT WAS RETURNED AND EVALUATED. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). STERILITY HAD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-102070 ITEM NAME TPRLC XR FP TYPE1 PPS 7X134MM LOT # 7309365 51-103170 ITEM NAME TPRLC 133 T1 PPS SO 17X154MM LOT # 7128215 51-105130 ITEM NAME TPRLC XR T1 PPS 13X146MM LOT # 7220813 51-145130 ITEM NAME TPRLC XR MP T1 PPS 13X111MM LOT # 6985718 51-103160 ITEM NAME TPRLC 133 T1 PPS SO 16X152MM LOT # 6396595 51-145140 ITEM NAME TPRLC XR MP T1 PPS 14X113MM LOT # 7220877 51-106160 ITEM NAME TPRLC 133 MP TYPE1 PPS SO 16.0 LOT # 7089491. 51-145160 ITEM NAME TPRLC XR MP T1 PPS 16X117MM LOT # 3684183. 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 EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE INSPECTING THE PRODUCT, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237985 TPRLC XR FP TYPE1 PPS 7X134MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 7309365 00880304516908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE H11