BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS SO 17X154MM

    MDR report key: 21815120 · Received April 10, 2025

    Report

    Report Number
    0001825034-2025-01064
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 18, 2025
    Report Date
    July 7, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-104150 ITEM NAME: TPRLC 133 T1 PPS HO 15X150MM, LOT#: 7121814. 51-100050 ITEM NAME: TPRLC 133 FP TYPE1 PPS SO 5.0, LOT#: 7031941. 51-145140 ITEM NAME: TPRLC XR MP T1 PPS 14X113MM, LOT#: 7220877. 51-106170 ITEM NAME: TPRLC 133 MP TYPE1 PPS SO 17.0, LOT#: 6619524. 51-106140 ITEM NAME: TPRLC 133 MP TYPE1 PPS SO 14.0, LOT#: 6806893. 51-103160 ITEM NAME: TPRLC 133 T1 PPS SO 16X152MM, LOT#: 6757692. 51-106150 ITEM NAME: TPRLC 133 MP TYPE1 PPS SO 15.0, LOT#: 7011684. 51-145160 ITEM NAME: TPRLC XR MP T1 PPS 16X117MM, LOT#: 6527601. 51-145140 ITEM NAME: TPRLC XR MP T1 PPS 14X113MM, LOT#: 6656598. 51-105150 ITEM NAME: TPRLC XR T1 PPS 15X150MM, LOT#: 6283154. 51-105150 ITEM NAME: TPRLC XR T1 PPS 15X150MM, LOT#: 6904300. 51-105110 ITEM NAME: TPRLC XR T1 PPS 11X142MM, LOT#: 7114095. G2: FOREIGN: JAPAN. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3;H6. PRODUCT WAS RETURNED AND EVALUATED. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). THE PACKAGE WAS NOTED TO BE PUNCTURED, AND 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 WHEN 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.

    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
    1454996 TPRLC 133 T1 PPS SO 17X154MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 7309370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown