BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC 133 FP TYPE1 PPS

    MDR report key: 9935120 · Received April 8, 2020

    Report

    Report Number
    0001825034-2020-01555
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 13, 2020
    Report Date
    June 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    PMA / PMN Number
    K103755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION CONFIRMED WHITE DEBRIS WITHIN THE STERILE PACKAGING. THE INSERT HAS BEEN DAMAGED SUCH THAT PARTICLES HAVE DETACHED FROM THE INSERT AND ARE FLOATING WITHIN THE STERILE BARRIER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE EVENT IS BEING REVIEWED THROUGH THE CAPA PROCESS. THE DEVICE EVALUATION FOUND NO MALFUNCTION AND THE EVENT DID NOT CONTRIBUTE TO INJURY, THEREFORE THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 51-105170/ TPRLC T1/LOT# 3856424, ITEM # 51-104150/ TPRLC 133 T1/LOT# 3450045, ITEM # 51-103140/ TPRLC 133 T1/LOT# 3590223, ITEM # 51-107160/ TPRLC 133 MP/LOT# 3163844, ITEM # 51-107130/ TPRLC 133 MP/LOT# 3781201. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01548, 0001825034-2020-01551, 0001825034-2020-01552, 0001825034-2020-01553, 0001825034-2020-01554.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING THE REVIEW OF INVENTORY, DEBRIS WAS FOUND WITHIN THE STERILE PACKAGING. NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404397 TAPERLOC 133 FP TYPE1 PPS PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. NI 3450146

    Patients

    Seq Age Sex Outcome Treatment
    1