BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 21949883 · Received May 2, 2025

    Report

    Report Number
    0001825034-2025-01309
    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
    00880304498341
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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.

    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. 51-105170 ITEM NAME TPRLC XR T1 PPS 17X154MM LOT # 7224452. 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. 51-105140 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.

    Description of Event or Problem · 0

    NO FURTHER 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
    194521 TAPERLOC COMPLETE PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 3697093 00880304498341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE H11