BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA FIXED BEARING ARTICULAR SURFACE

    MDR report key: 7132329 · Received December 19, 2017

    Report

    Report Number
    3007963827-2017-00291
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 WERE TRENDS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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

    ARTICULAR SURFACE WAS RETURNED FOR EVALUATION. VISUAL EVALUATION INDICATES THAT THE DOVE TAIL FEATURE AS WELL AS THE MEDIAL AND LATERAL RAILS ARE DAMAGED FLARED OUT. DIMENSIONAL EVALUATION INDICATES THAT THE DEVICE WAS MADE TO PRINT WHERE MEASURED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. ROOT CAUSE CANNOT 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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 THE ARTICULAR SURFACE WOULD NOT SEAT INTO THE TIBIAL BASE. THIS WAS REPEATED WITH THE SAME RESULTS. A NEW ARTICULAR SURFACE WAS USED TO COMPLETE THE CASE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911066 PERSONA FIXED BEARING ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 63793831

    Patients

    Seq Age Sex Outcome Treatment
    1