BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD, M, ø 36/0, TAPER 12/14

    MDR report key: 19088896 · Received April 11, 2024

    Report

    Report Number
    0009613350-2024-00136
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    November 9, 2023
    Report Date
    June 20, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024386495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. 36MM I.D. SIZE F NEUTRAL LINER ITEM# 20103606 LOT# 65223950; G7 OSSEOTI 4 HOLE SHELL 56MM F ITEM# 110010246 LOT # 7132248. G2. REPORT SOURCE: SWEDEN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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

    IT WAS REPORTED THAT DURING A SCHEDULED FOLLOW-UP VISIT FOR A CLINICAL STUDY, ONE PATIENT REPORTED SEVERE HIP PAIN IN CONTRALATERAL HIP APPROXIMATELY 1 YEAR POST-IMPLANTATION. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445219 COCR HEAD, M, ø 36/0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A 3107862 00889024386495

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other SEE H11 NARRATIVE