BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX DELTA 32MM -4MM HEAD

    MDR report key: 21731610 · Received March 31, 2025

    Report

    Report Number
    0009613350-2025-00204
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 29, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # EP-053256, RINGLOC-X E1 H/W 56/32MM, LOT # 3275379. G2: REPORT SOURCE AUSTRALIA. 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

    (B)(4). NO PRODUCT WAS RETURNED FOR EXAMINATION. SOME IMAGES ARE AVAILABLE, AND THE CERAMIC HEAD IS ALSO SHOWN. THE IMAGES WERE TAKEN IMMEDIATELY AFTER THE REVISION SURGERY, AND THE COMPONENT REMAINS IN A NON-CLEANED, CONTAMINATED CONDITION. VISUAL ASSESSMENT REVEALS DAMAGES TO THE SURFACE OF THE CERAMIC HEAD, METALLIC SMEARING AND SOME SCRATCHES CAN BE SEEN. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. HOWEVER, THE CERAMTEC INSPECTION CERTIFICATE CONFIRMED NO ABNORMALITIES AND DEVIATIONS. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AP VIEW OF THE BILATERAL HIPS DEMONSTRATES BILATERAL TOTAL HIP ARTHROPLASTIES. NO ACUTE FRACTURE. NO RADIOLUCENCY. NO DISLOCATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. 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 THE PATIENT UNDERWENT A RIGHT HIP REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. PREVIOUS DISLOCATIONS WERE REDUCED WITHOUT OPENING THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955021 UNKNOWN BIOLOX DELTA 32MM -4MM HEAD PROSTHESIS, HIPS LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R