BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC XR MP T1 PPS

    MDR report key: 9804905 · Received March 9, 2020

    Report

    Report Number
    0001825034-2020-01009
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 27, 2020
    Report Date
    June 25, 2020
    Manufacturer
    .
    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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE BLISTER CARTON IS SHATTERED. NOT ALL PIECES OF THE BLISTER CARTON WERE RETURNED. THE POUCH IS TORN SUCH THAT THE STEM IS ABLE TO PROTRUDE THROUGH THE TEAR. BLACK DEBRIS WAS OBSERVED WITHIN THE POUCH. THE OUTER PACKAGING IS ROUGHED UP FROM HANDLING BUT NO MAJOR WAS OBSERVED. THE STERILE SEAL REMAINS INTACT. THE STERILITY OF THE DEVICE HAS BEEN COMPROMISED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE POROUS COATING TO SHED FROM THE IMPLANT. 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). CONCOMITANT MEDICAL PRODUCTS : TPRLC 133 T1 PPS HO 17X154MM, CAT# 51-104170 LOT# 6170627, TPRLC 133 T1 PPS HO 17X154MM, CAT# 51-104170 LOT# 6130017. FOREIGN COUNTRY: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01010, 0001825034-2020-01011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILE PACKAGES WERE FOUND DAMAGED. NO PATIENTS WERE INVOLVED. 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
    268507 TAPERLOC XR MP T1 PPS PROSTHESIS, HIP KWZ . NI 6156281

    Patients

    Seq Age Sex Outcome Treatment
    1