BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 17.0 1

    MDR report key: 9293756 · Received November 7, 2019

    Report

    Report Number
    0001825034-2019-05008
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    November 1, 2019
    Report Date
    March 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    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. D4: UDI#: (B)(4). THE EVENT WAS CONFIRMED WITH PRODUCT RECEIVED. VISUAL INSPECTION IDENTIFIED BLACK DEBRIS INSIDE THE SEALED STERILE PACKAGING, CONSISTENT WITH THE APPEARANCE OF POROUS COATING. WHITE DEBRIS INSIDE THE STERILE PACKAGING WAS ALSO IDENTIFIED, CONSISTENT WITH THE APPEARANCE OF FOAM SHEDDING FROM THE FOAM PACKAGING. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THESE PRODUCTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE POROUS COATING TO SHED FROM THE IMPLANT AND TRANSFER TO THE PACKAGING AND FOAM PACKAGING TO SHED. A CORRECTIVE ACTION WAS OPENED TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS CAPA, THE POUCH IS BEING IMPROVED TO USE A STRONGER MATERIAL (NYLON), AND FOAM END CAPS ARE BEING ADDED. ALSO, THE ORIENTATION THE DEVICES ARE PACKED IN THE SHIPPER BOX IS MOVING FROM VERTICAL TO HORIZONTAL, AND THE THICKNESS OF THE SHIPPER BOX HAS BEEN INCREASED. 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: CATALOG#: 51-149060 TPRLC XR MP FP T1 PPS 6X97.5MM MM T1 LOT#: 6130032. CATALOG#: 51-105150 TPRLC XR T1 PPS 15X150MM MM T1 LOT#: 6002105. CATALOG#: 51-105160 TPRLC XR T1 PPS 16X152MM MM T1 LOT#: 3751535. FOREIGN: (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: 0001825034-2019-05000, 0001825034-2019-05002, 0001825034-2019-05007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS IN THE STERILE PACKAGING WAS OBSERVED DURING INCOMING INSPECTION. 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
    1086308 TPRLC 133 MP TYPE1 PPS SO 17.0 1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3791251

    Patients

    Seq Age Sex Outcome Treatment
    1