BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC XR MP T1 PPS

    MDR report key: 10032054 · Received May 7, 2020

    Report

    Report Number
    0001825034-2020-01934
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 16, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K120030
    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. EVALUATION OF THE PHOTOGRAPHS PROVIDED CONFIRMED THE STERILE PACKAGING BLISTER AND FOAM IS DAMAGED AND THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THEREFORE, THE REPORTED EVENT IS CONFIRMED. STERILITY WAS NOT COMPROMISED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND THE ROOT CAUSE OF THE REPORTED EVENT IT LIKELY TO BE DAMAGE DURING TRANSIT CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE EVENT IS BEING REVIEWED THROUGH THE CAPA PROCESS. THE DEVICE EVALUATION FOUND THE PRODUCT TO BE CONFORMING AND STERILITY NOT COMPROMISED. FURTHER, THE EVENT DID NOT CONTRIBUTE TO A SERIOUS 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. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 51-105160 / TPRLC XR T1 PPS/ LOT #6133648. ITEM# 51-108050/ TPRLC 133 MP T1 PPS SO/LOT # 3644078. ITEM# 51-145140/ TPRLC XR MP T1 PPS/ LOT# 3908804. ITEM# 51-107150/ TPRLC 133 MP TYPE1 PPS HO/ LOT# 3195545. ITEM# 51-109060/ TLOC 133 MP SP T1 PPSHO / LOT# 3714456. REPORT SOURCE: FOREIGN (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01932, 0001825034-2020-01933, 0001825034-2020-01935, 0001825034-2020-01936, 0001825034-2020-01937.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CIRCULATION OF PRODUCT, DEBRIS WAS FOUND INSIDE THE STERILE PACKAGING. THERE WAS 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
    498357 TAPERLOC XR MP T1 PPS PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. NI 2866770

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10.