BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC 133 FP TYPE1 PPS HO 5.0 T1

    MDR report key: 9900150 · Received March 30, 2020

    Report

    Report Number
    0001825034-2020-01378
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 19, 2020
    Report Date
    June 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K103755
    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. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH VISUAL INSPECTION. THE RETURNED PACKAGES SHOWED WHITE DEBRIS WITHIN THE STERILE PACKAGING. THE INSERTS WERE DAMAGED SUCH THAT PARTICLES HAD BECOME DETACHED TO FLOAT FREELY WITHIN THE STERILE PACKAGING. THE DEBRIS WAS CONSISTENT WITH THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THE BLISTER SEAL REMAINED INTACT AND THE OUTER PACKAGE APPEARED ROUGHENED THROUGH HANDLING WITH NO NOTICEABLE DAMAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. 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). MODEL #: (01)00880304499065(17)251210(10)3692721. CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 FP TYPE1 PPS HO 5.0 T1 CAT# 51-101050 LOT# 3590153, TPRLC 133 T1 PPS HO 17X154MM 4MM T1 CAT# 51-104170 LOT# 3706660, TPRLC XR FP TYPE1 PPS 5X130MM 1 CAT# 51-102050 LOT# 3368426, TPRLC XR T1 PPS 17X154MM MM T1 CAT# 51-105170 LOT# 3096162, TPRLC 133 FP TYPE1 PPS HO 5.0 T1 CAT# 51-101050 LOT# 2588486. (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: 0001825034-2020-01379, 0001825034-2020-01380, 0001825034-2020-01381, 0001825034-2020-01382, 0001825034-2020-01383.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS IDENTIFIED WITHIN 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
    364812 TAPERLOC 133 FP TYPE1 PPS HO 5.0 T1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 3692721

    Patients

    Seq Age Sex Outcome Treatment
    1