BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC XR T1 PPS

    MDR report key: 9878990 · Received March 25, 2020

    Report

    Report Number
    0001825034-2020-01313
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 6, 2020
    Report Date
    July 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    K120030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) UPDATED: B4, B5, D10, G4, H1, H2, H3, H6, AND H10 REPORTED EVENT IS CONSIDERED CONFIRMED AS 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. STERILITY WAS NOT COMPROMISED. DEVICE HISTORY RECORD 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. 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). MODEL NUMBER: (01)00880304517172(17)250804(10)3604995. CONCOMITANT MEDICAL PRODUCTS: TPRLC XR T1 PPS 17X154MM MM T1 CAT# 51-105170 LOT# 3201696, TPRLC XR T1 PPS 16X152MM MM T1 CAT# 51-105160 LOT# 2867464, TPRLC 133 T1 PPS HO 16X152MM 2MM T1 CAT# 51-104160 LOT# 2775665, TPRLC 133 T1 PPS HO 16X152MM 2MM T1 CAT# 51-104160 LOT# 2887182, TPRLC XR T1 PPS 15X150MM MM T1 CAT# 51-105150 LOT# 2973390. (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: 0001825034-2020-01308, 0001825034-2020-01309, 0001825034-2020-01311, 0001825034-2020-01312, 0001825034-2020-01314.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS IDENTIFIED WITHIN STERILE PACKAGING. 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
    344096 TAPERLOC XR T1 PPS PROSTHESIS, HIP OQG ZIMMER BIOMET, INC. NI 3604995

    Patients

    Seq Age Sex Outcome Treatment
    1