BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC XR MP T1 PPS

    MDR report key: 10337458 · Received July 29, 2020

    Report

    Report Number
    0001825034-2020-02925
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 3, 2020
    Report Date
    October 1, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    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 WAS CONFIRMED BY REVIEW OF PROVIDED PHOTOGRAPHS. PHOTOGRAPHS REVEALED DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT. THE EVENT IS BEING FURTHER 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. UDI# (B)(4). ITEM# 51-105130/ TPRLC XR T1 PPS /LOT # 2920980, ITEM# 51-104120/ TPRLC 133 T1 PPS HO / LOT #3677492, ITEM# 51-107150/TPRLC 133 MP TYPE1 PPS LOT # 3769795, ITEM# 51-104140/ TPRLC 133 T1 PPS HO / LOT #3387180, ITEM# 51-104160/TPRLC 133 T1 PPS HO/ LOT # 3135988. SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -02858, 0001825034 -2020 -02859, 0001825034 -2020 -02860, 0001825034 -2020 -02923, 0001825034 -2020 -02924.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF PRODUCT IN WAREHOUSE, DEBRIS WAS FOUND IN 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
    805832 TAPERLOC XR MP T1 PPS PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 6274221

    Patients

    Seq Age Sex Outcome Treatment
    1