BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 16.0

    MDR report key: 21761438 · Received April 3, 2025

    Report

    Report Number
    0001825034-2025-00973
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 11, 2025
    Report Date
    July 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304513556
    PMA / PMN Number
    K110400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-145170 TPRLC XR MP T1 PPS 17X119MM 6893651. 51-104140 TPRLC 133 T1 PPS HO 14X148MM 7128209. 51-104130 TPRLC 133 T1 PPS HO 13X146MM 7130654. 51-106160 TPRLC 133 MP TYPE1 PPS SO 16.0 3777625. 51-108050 TPRLC 133 MP T1 PPS SO 5X95MM 6185618. 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 AND/OR CORRECTED INFORMATION. UPDATED: D9, G3, G6, H2, H3, H6, H10. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (POUCH). 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED ITEMS THAT THE STERILE PACKAGING WAS IDENTIFIED 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 TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732178 TPRLC 133 MP TYPE1 PPS HO 16.0 PROSTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 6866813 00880304513556

    Patients

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