BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS HO 7.0

    MDR report key: 21584449 · Received March 12, 2025

    Report

    Report Number
    0001825034-2025-00668
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 18, 2025
    Report Date
    June 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304489769
    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: 51-105140 TPRLC XR T1 PPS 14X148MM 7216800 51-104130 TPRLC 133 T1 PPS HO 13X146MM 6278597 51-107150 TPRLC 133 MP TYPE1 PPS HO 15.0 6626698 51-104160 TPRLC 133 T1 PPS HO 16X152MM 7136712 51-100050 TPRLC 133 FP TYPE1 PPS SO 5.0 7024050 51-107150 TPRLC 133 MP TYPE1 PPS HO 15.0 3769796 51-106170 TPRLC 133 MP TYPE1 PPS SO 17.0 3581736 51-107150 TPRLC 133 MP TYPE1 PPS HO 15.0 6603111 51-109060 TLOC 133 MP SP T1 PPSHO 6X97.5 6418312 51-104140 TPRLC 133 T1 PPS HO 14X148MM 7142512 51-106130 TPRLC 133 MP TYPE1 PPS SO 13.0 7130662 51-106170 TPRLC 133 MP TYPE1 PPS SO 17.0 7240410 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED, AND THE STERILE PACKAGING WAS DETERMINED TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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
    1614789 TPRLC 133 FP TYPE1 PPS HO 7.0 PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A 3799152 00880304489769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.