BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D36-CM BIOLOX DELTA CERAMIC FEMORAL HEAD

    MDR report key: 21980241 · Received May 7, 2025

    Report

    Report Number
    3008668801-2025-00112
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    July 11, 2017
    Report Date
    February 26, 2026
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    LZO
    PMA / PMN Number
    K223745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISLOCATION (LEADING TO REVISION) INVOLVING A HIC 36 C BIOLOX DELTA CERAMIC LINER WAS REPORTED. CONCLUSIONS: NO TECHNICAL INVESTIGATION WAS PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. DOCUMENTARY INFESTATION: LOT: 1605135A MANUFACTURING ORDER: (B)(4) - (B)(4) UNITS MANUFACTURED. NO NON-CONFORMANCE OBSERVED FOR THIS BATCH (B)(4) UNITS PUT ON THE MARKET BY SERF IN (B)(6) 2016 NO OTHER COMPLAINTS HAVE BEEN RECORDED ON THIS BATCH IN THE ABSENCE OF MORE INFORMATION, CAUSE NOT ESTABLISHED CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED.

    Description of Event or Problem · 0

    PATIENT ENCOUNTERED ITERATIVE DISLOCATION LEADING TO THE REVISION OF THE CUP, THE INSERT AND THE HEAD.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128475 D36-CM BIOLOX DELTA CERAMIC FEMORAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 1605135A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization| R