BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MOM HIP

    MDR report key: 4223516 · Received November 4, 2014

    Report

    Report Number
    0001825034-2014-08517
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    November 14, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. IT IS NOT KNOWN WHETHER THE PATIENTS WHO EXPERIENCED POOR RESULTS WERE IMPLANTED WITH BIOMET PRODUCT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY ELIZABETH ROBINSON, JOHANN HENCKEL, SHIRAZ SABAH, KESHTHRA SATCHITHANANDA, JOHN SKINNER, AND ALISTER HART IN ACTA ORTHOPAEDICA 2014; 85 (6). MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/ UPDATED INFORMATION. EVENT DESCRIPTION, PATIENT/ DEVICE CODES, EVALUATION CODES, MANUFACTURER NARRATIVE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "CROSS-SECTIONAL IMAGING OF METAL-ON-METAL HIP ARTHROPLASTIES: CAN WE SUBSTITUTE MARS MRI WITH CT?¿ WHICH ATTEMPTS TO DETERMINE WHETHER CT IS A SUITABLE SUBSTITUTE FOR MARS MRI IN EVALUATION OF THE PAINFUL MOM-HA. THIS STUDY INVOLVED FIFTY (50) PATIENTS WHO HAD UNEXPLAINED PAIN. THREE OF THE FIFTY PATIENTS RECEIVED A BIOMET MANUFACTURED HIP (1 RECAP MAGNUM, ONE TAPERLOC MAGNUM AND ONE BIOMET MODULAR PROSTHESIS). THE JOURNAL ARTICLE REPORTS ADVERSE EVENTS DUE TO THE FOLLOWING REASONS: TWENTY-FIVE (25) PSEUDOTUMORS WERE DETECTED. FIFTEEN (15) REPORTS OF OSTEOLYSIS. EVIDENCE OF MODERATE OR SEVERE MUSCLE ATROPHY WAS PRESENT TO VARYING EXTENTS IN FORTY-NINE OF FIFTY PATIENTS WITH UNEXPLAINED HIP PAIN. IT IS UNKNOWN WHICH HIP SYSTEM THE PATIENTS THAT EXPERIENCED THE ADVERSE EVENTS LISTED ABOVE RECEIVED. THE JOURNAL ARTICLE CONCLUDES THAT, WHILE BOTH MODALITIES HAVE BEEN USED SUCCESSFULLY TO EVALUATE THE SOFT TISSUES OF SUCH PATIENTS, IT WAS FOUND THAT MARS MRI IS SUPERIOR TO CT FOR THE DIAGNOSIS AND CHARACTERIZATION OF PSEUDOTUMOR AND MUSCLE ATROPHY WITH A VIEW TO PATIENT MANAGEMENT AND OPERATIVE PLANNING. IN ADDITION, IT WAS DETERMINED THAT CT IS A MORE EFFECTIVE MODALITY FOR DETECTING PERIPROSTHETIC BONY CHANGES IN MOM HIPS THAN MARS MRI. BASED ON THE FINDINGS, THE AUTHORS ADVOCATE A MULTIMODAL ASSESSMENT OF SYMPTOMATIC PATIENTS TO DETECT THE FULL SPECTRUM OF MOM-ASSOCIATED PATHOLOGIES IN THE MOST SENSITIVE WAY. FOR THESE PATIENTS, A SINGLE-MODALITY ALGORITHM WOULD PROVE TO BE LESS USEFUL.

    Description of Event or Problem · 1

    THIS RECORD WILL ADDRESS: THE JOURNAL ARTICLE IDENTIFIES PSEUDOTUMORS WERE DIAGNOSED IN 25 OF 50 HIPS. IT IS UNKNOWN WHICH HIP SYSTEM THE PATIENTS THAT EXPERIENCED THE ADVERSE EVENTS LISTED ABOVE RECEIVED. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706997 UNKNOWN MOM HIP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R