BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX DELTA TAPER LINER

    MDR report key: 15637305 · Received October 20, 2022

    Report

    Report Number
    0009613350-2022-00528
    Event Type
    Injury
    Date Received
    October 20, 2022
    Report Date
    November 29, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN BIOLOX DELTA FEMORAL HEAD 48MM; UNKNOWN MAXERA 58MM ACETABULUM. REPORT SOURCE ¿ FOREIGN ¿ CANADA. JOURNAL: LINER DISSOCIATION IN A LARGE-DIAMETER CERAMIC-BEARING ACETABULAR COMPONENT: A REPORT OF FIVE CASESLAZAROS KOSTRETZIS, SAGI MARTINOV, MARTIN LAVIGNE, VINCENT MASSÉ, PASCAL-ANDRÉ VENDITTOLI: BMC MUSCULOSKELETAL DISORDERS (2022); HTTPS://DOI.ORG/10.1186/S12891-022-05082-6. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H10. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 AND 1/2 YEARS POST IMPLANTATION DUE TO ABRUPT PAIN IN THE LEFT GROIN AND BUTTOCK REGION. RADIOGRAPHIC EVIDENCE DISPLAYED MILLIMETRIC SEPARATION OF THE CERAMIC INSERT AND PNEUMARTHROSIS. DURING THE REVISION, THE CERAMIC LINER WAS FOUND MISALIGNED. DURING EXTRACTION OF THE ACETABULAR COMPONENT, IT WAS IMPOSSIBLE TO SEPARATE THE CERAMIC LINER FROM THE TITANIUM SHELL. TAPER MODULAR JUNCTION WEAR AND CORROSION SIGNS WERE OBSERVED, WITHOUT METALLOSIS. A 4MM LARGER THAN THE INDEX, MAXERA COMPONENT WAS IMPLANTED. THE PATIENT FOLLOWED STANDARD POST-OPERATIVE REHABILITATION WITHOUT FURTHER COMPLICATIONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    2002619 UNKNOWN BIOLOX DELTA TAPER LINER HIP PROSTHESIS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Hospitalization| R SEE H10 NARRATIVE