BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN ALL POLYETHYLENE PATELLA

    MDR report key: 6975892 · Received October 25, 2017

    Report

    Report Number
    3007963827-2017-00270
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    August 17, 2017
    Report Date
    November 10, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). (B)(4). BOTH ALL POLY PATELLA PARTS WERE RETURNED FOR EVALUATION. BOTH PARTS HAS THE INNER AND OUTER CAVITY LIDS BONDED TOGETHER. THE ISSUE OF BONDED INNER AND OUTER LIDS IS CONFIRMED FOR BOTH PARTS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THIS INVESTIGATION CONCLUDED THAT THERE IS NO SYSTEMIC ISSUE WITH THE SUBASSEMBLY PROCESS AND SUFFICIENT CONTROLS ARE IN PLACE TO ENSURE PRODUCT MEETS SPECIFICATION THEREFORE, MAN & METHOD HAVE BEEN RETAINED AS PROBABLE ROOT CAUSES FOR THIS ISSUE. 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

    BOTH ALL POLY PATELLA PARTS WERE RETURNED FOR EVALUATION. BOTH PARTS HAS THE INNER AND OUTER CAVITY LIDS BONDED TOGETHER. THE ISSUE OF BONDED INNER AND OUTER LIDS IS CONFIRMED FOR BOTH PARTS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THIS INVESTIGATION CONCLUDED THAT THERE IS NO SYSTEMIC ISSUE WITH THE SUBASSEMBLY PROCESS AND SUFFICIENT CONTROLS ARE IN PLACE TO ENSURE PRODUCT MEETS SPECIFICATION THEREFORE, MAN & METHOD HAVE BEEN RETAINED AS PROBABLE ROOT CAUSES FOR THIS ISSUE. 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 · 1

    IT WAS REPORTED THAT WHILE OPENING THE PACKAGE DURING A TOTAL KNEE PROCEDURE, THE INNER FOIL COVER WAS PEELED OFF ALONG WITH THE OUTER LAYER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758167 NEXGEN ALL POLYETHYLENE PATELLA PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63436589

    Patients

    Seq Age Sex Outcome Treatment
    1