BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR T1 PPS 13X146MM

    MDR report key: 22025729 · Received May 15, 2025

    Report

    Report Number
    0001825034-2025-01413
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 22, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304517141
    PMA / PMN Number
    K120030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-145160 TPRLC XR MP T1 PPS 16X117MM 3684183. 51-107150 TPRLC 133 MP TYPE1 PPS HO 15.0 7024048. 51-102040 TPRLC XR FP TYPE1 PPS 4X128MM 7198022. 51-103170 TPRLC 133 T1 PPS SO 17X154MM 6103542. 51-109050 TLOC 133 MP SP T1 PPS HO 5X95 7224177. 51-104090 TPRLC 133 T1 PPS HO 9X137MM 6934291. 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, B5, D9, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE SUSPECTED PRODUCT. VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED DAMAGE TO THE STERILE PACKAGING (POUCH). STERILITY HAS BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY SEARCH WAS NOT PERFORMED AS THE PACKAGING DESIGN HAS BEEN REMEDIATED. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND A PACKAGING DESIGN ISSUE. CORRECTIVE ACTIONS HAVE BEEN PREVIOUSLY RAISED TO IMPLEMENT IMPROVED PACKAGING CHANGES. THESE PACKAGING CHANGES WILL REDUCE THE NUMBER OF TRANSIT RELATED PACKAGING DAMAGE EVENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, H11. VISUAL EVALUATION OF THE PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (POUCH). STERILITY HAS BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND A PACKAGING DESIGN ISSUE. THIS COMPLAINT HAS BEEN CONFIRMED BY EVALUATION OF THE PROVIDED PHOTOS. A COMPLAINT HISTORY SEARCH WAS NOT PERFORMED AS THE PACKAGING DESIGN HAS BEEN REMEDIATED AS A PART OF CORRECTIVE ACTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CIRCULATED ITEMS WERE INSPECTED AND THAT THE INNER POUCH WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346977 TPRLC XR T1 PPS 13X146MM PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 7136705 00880304517141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE