BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM PATELLA ALL POLY

    MDR report key: 10364803 · Received August 4, 2020

    Report

    Report Number
    0001822565-2020-02818
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BIOMET CC CRUCIATE TRAY 67MM CATALOG # 141232 LOT # 582040; AGC ANATOMIC POR FMRL 60 RIGHT CATALOG # 152732 LOT # 437760; GEN 4 CEMVACPAC 80 GRSINGLE PK CATALOG # 402401 LOT # 069440; UNIVERSAL Z/HALL STYL 19.7X100 CATALOG # 516065 LOT # 88685; BIOMET ARCOM PAT ALL POLY 25MM CATALOG # CP102790 LOT # 269420; AGC TRAD PRI TIB BEAR 12X63/67 CATALOG # 151006 LOT # 390650. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-03008, 0001822565-2020-02782. HETEROTOPIC OSSIFICATION IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, CAUSING PAIN AND IRRITATION TO THE SURROUNDING TISSUES. THE ONLY TREATMENT IS SURGICAL EXCISION OR SHAVING DOWN TO SMOOTH OUT THE EXCESS BONE. AS TIME FRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. PLEASE CONSIDER COMPLAINT CATEGORY MEDICAL: HETEROTOPIC OSSIFICATION. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO HETEROTROPIC BONE OSSIFICATION, WHICH CONTRIBUTED TO THE PATIENT EXPERIENCING LIMITED RANGE OF MOTION, PAIN, AND STIFFNESS. THE SURGEON REMOVED EXCESS BONE AND REPLACED THE ARTICULAR SURFACE PROSTHESIS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826548 BIOMET ARCOM PATELLA ALL POLY PROSTHESIS, KNEE OIY ZIMMER BIOMET, INC. N/A 269420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R