BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAXERA CUP

    MDR report key: 15606478 · Received October 14, 2022

    Report

    Report Number
    0001822565-2022-02964
    Event Type
    Injury
    Date Received
    October 14, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    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). REPROT 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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED DARK DEBRIS, BIO-DEBRIS, AND WEAR ON THE EXPLANTED MAXERA CUP. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURES. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BILATERAL TOTAL HIP ARTHROPLASTIES WITH EVIDENCE OF RIGHT HIP CERAMIC LINER DISPLACEMENT AS WELL AS PNEUMARTHROSIS. 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 A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS POST IMPLANTATION AFTER EXPERIENCING A SHARP PAIN. RADIOGRAPHIC EVIDENCE DISPLAYED CERAMIC INSERT SEPARATION AND PNEUMARTHROSIS. DURING THE SURGERY, THE CAPSULE WAS FOUND WIDE-OPEN POSTERIORLY, WITH A LARGE COLLECTION OF YELLOWISH FLUID, THE TITANIUM SHELL HAD WEAR SIGNS WITH TITANIUM DEBRIS, AND SIGNS OF CORROSION. THE CERAMIC LINER WAS DISPLACED AND FOUND MOBILE. THE MAXERA CUP WAS REMOVED AND REPLACED WITH A 4MM LARGER CUP. THE PATIENT WAS OBSERVED FOR 8 MONTHS, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. HTTPS://DOI.ORG/10.1186/S12891-022-05082-6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780674 UNKNOWN MAXERA CUP PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R UNKNOWN BIOLOX HEAD| UNKNOWN BIOLOX LINER| UNKNOWN STEM