BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 21949865 · Received May 2, 2025

    Report

    Report Number
    0001825034-2025-01304
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 11, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304517189
    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: 51-100040, ITEM NAME TPRLC 133 FP TYPE1 PPS SO 4.0, LOT # 6238377. 51-104170, ITEM NAME TPRLC 133 T1 PPS HO 17X154MM, LOT # 7220855. 51-145170, ITEM NAME TPRLC XR MP T1 PPS 17X119MM, LOT # 7104665. 51-107170, ITEM NAME TPRLC 133 MP TYPE1 PPS HO 17.0, LOT # 7257528. 51-107170, ITEM NAME TPRLC 133 MP TYPE1 PPS HO 17.0, LOT # 7247937. 51-106170, ITEM NAME TPRLC 133 MP TYPE1 PPS SO 17.0, LOT # 6639627. 51-104170, ITEM NAME TPRLC 133 T1 PPS HO 17X154MM, LOT # 6130017. 51-104140, ITEM NAME TPRLC 133 T1 PPS HO 14X148MM, LOT # 7114087. 51-145140, ITEM NAME TPRLC XR MP T1 PPS 14X113MM, LOT # 6527595. 51-104170, ITEM NAME TPRLC 133 T1 PPS HO 17X154MM, LOT # 6924051. 51-103170, ITEM NAME TPRLC 133 T1 PPS SO 17X154MM, LOT # 3697093. 51-105140, ITEM NAME TPRLC XR T1 PPS 14X148MM, LOT # 6852411. 51-106170, ITEM NAME TPRLC 133 MP TYPE1 PPS SO 17.0, LOT # 6118645. 51-104140, ITEM NAME TPRLC 133 T1 PPS HO 14X148MM, LOT # 3938957. 51-105160, ITEM NAME TPRLC XR T1 PPS 16X152MM, LOT # 6238851. 51-145150, ITEM NAME TPRLC XR MP T1 PPS 15X115MM, LOT # 7281467. 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. THE FOLLOWING SECTIONS WERE CORRECTED: D1. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). STERILITY HAS NOT 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 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 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 INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657090 TAPERLOC COMPLETE PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 7224452 00880304517189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE H11