BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL BLOCK AND SCREWS PRECOAT SIZE 6 5 MM THICKNESS

    MDR report key: 6305690 · Received February 6, 2017

    Report

    Report Number
    0001822565-2017-00602
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 9, 2017
    Report Date
    April 4, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK946150
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO POSSIBLE PRODUCT IDENTIFICATIONS WERE REPORTED, HOWEVER ONLY ONE DEVICE EXPERIENCED THE REPORTED ISSUE, AND IT IS UNKNOWN WHICH OF THE TWO POSSIBLE LOT NUMBERS WAS MISSING THE SCREW COMPONENTS. PRODUCT DETAILS OF BOTH PRODUCTS ARE BELOW: PART: 00598800626 LOT: 60933606 MANUFACTURE DATE: APR 21, 2008 EXPIRATION DATE: APR 30, 2018 510K: K946150 PRODUCT CODE: JWH PART: 00598800626 LOT: 63122084 MANUFACTURE DATE: AUG 5, 2015 EXPIRATION DATE: JUL 31, 2025 510K: K946150 PRODUCT CODE: JWH UDI: (B)(4). REPORTED EVENT WAS CONFIRMED THROUGH INVESTIGATION. PRODUCT WAS NOT RETURNED, SO EVALUATION OF THE PHYSICAL PRODUCT COULD NOT BE CONDUCTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT. REFERENCE:0001822565-2017-00611.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANT WAS MISSING SCREWS FROM THE PACKAGING. THE IMPLANT WAS STILL IMPLANTED; HOWEVER, ANOTHER PACKAGE HAD TO BE OPENED TO OBTAIN SCREWS. NO KNOWN ADVERSE EVENT WAS REPORTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANT WAS MISSING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87174 TIBIAL BLOCK AND SCREWS PRECOAT SIZE 6 5 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1