BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL

    MDR report key: 7798366 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08257
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Date of Event
    July 25, 2018
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    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. REPORTED EVENT WAS CONFIRMED THROUGH RETURNED PRODUCT INSPECTION. INSPECTION OF THE INNER CAVITIES OF EACH BOX CONFIRMS THERE ARE DAMAGES TO THE CAVITIES. THE STERILE BARRIER WAS HOWEVER NOT BROKEN. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: 51-103090 ¿ TAPERLOC COMPLETE PRIMARY FEMORAL ¿ 6298825, 51-103090 - TAPERLOC COMPLETE PRIMARY FEMORAL - 6298833, 51-103090 ¿ TAPERLOC COMPLETE PRIMARY FEMORAL ¿ 6298837, 51-103160 ¿ TAPERLOC COMPLETE PRIMARY FEMORAL ¿ 6299191. 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 - 2018 - 08258, 0001825034 - 2018 - 08259, 0001825034 - 2018 - 08260, 0001825034 - 2018 - 08261.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE STERILE PACKAGING WAS FOUND TO BE DEFORMED DUE TO IMPACT OF THE INNER STEM DURING DISTRIBUTION. 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
    638056 TAPERLOC COMPLETE PRIMARY FEMORAL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6298825

    Patients

    Seq Age Sex Outcome Treatment
    1