BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAXERA 58MM CUP

    MDR report key: 15606506 · Received October 14, 2022

    Report

    Report Number
    0001822565-2022-02965
    Event Type
    Injury
    Date Received
    October 14, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction 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). FOREIGN: CANADA. REPORT SOURCE: 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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 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. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781760 UNKNOWN MAXERA 58MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Hospitalization| R UNKNOWN BIOLOX HEAD.| UNKNOWN BIOLOX LINER.| UNKNOWN STEM.