BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SMOOTH STRAIGHT IM 10MM X 90MM MODULAR STEM

    MDR report key: 6211017 · Received December 28, 2016

    Report

    Report Number
    0001825034-2016-05474
    Event Type
    Injury
    Date Received
    December 28, 2016
    Report Date
    March 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY INVESTIGATION RESULTS. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD FOR CP111644 LOT 974140 IDENTIFIED NO DEVIATIONS OR ANOMALIES. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: 423883, 150410, 130615, 130613, CP113824, 150411, CP114678, CP113455, CP111644. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE REPORTED ITEM AND PART AND LOT COMBINATION. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FLED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION. IT WAS INDICATED THAT THE PATIENT HAS A PERI PROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861134 OSS SMOOTH STRAIGHT IM 10MM X 90MM MODULAR STEM PROSTHESIS, KNEE JDI BIOMET ORTHOPEDICS N/A 974140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R