BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COPELAND SHOULDER

    MDR report key: 4178017 · Received October 16, 2014

    Report

    Report Number
    0001825034-2014-08068
    Event Type
    Injury
    Date Received
    October 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN; BRAND NAME - UNKNOWN; CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN ; DATE EXPLANTED - UNKNOWN. (B)(4). THE 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED,"STRESS-SHIELDING INDUCED BONE REMODELLING IN CEMENTLESS SHOULDER RESURFACING ARTHROPLASTY: A FINITE ELEMENT ANALYSIS AND IN-VIVO RESULTS," WHICH STATED CEMENTLESS SURFACE REPLACEMENT ARTHROPLASTY (CSRA) OF THE SHOULDER WAS DESIGNED TO PRESERVE THE INDIVIDUAL ANATOMY AND HUMERAL BONE STOCK. A MATTER OF CONCERN IN RESURFACING IMPLANTS REMAINS THE STRESS SHIELDING AND BONE REMODELING PROCESSES. THE STUDY EVALUATED THE LOAD TRANSFER AND BONE REMODELING PROCESSES OF CSRA IMPLANTS CONSIDERING TWO DIFFERENT GEOMETRICAL DESIGNS. ONE IS DESIGNED WITH A CONICAL-CROWN SHAPED RING AND IS MANUFACTURED BY A COMPETITOR. THE SECOND DESIGN, MANUFACTURED BY BIOMET INC., HAS A CENTRAL STEM. BOTH WERE STUDIED BY 3- DIMENSIONAL (3-D) FINITE ELEMENT ANALYSIS (FEA) AS WELL AS EVALUATION OF CONTACT RADIOGRAPHS FROM HUMAN CSRA RETRIEVALS. THE JOURNAL ARTICLE REPORTS THAT FOUR (4) REVISION PROCEDURES OCCURRED DUE TO GLENOID EROSION AND PAIN. THE ASSUMPTIONS OF THE FEA WERE CONFIRMED IN THE CSRA RETRIEVAL ANALYSIS WHICH SHOWED BONE APPOSITION AT THE OUTER IMPLANT RIM AND STEMS WITH HIGHLY REDUCED BONE STOCK BELOW THE CENTRAL IMPLANT SHELL. OVERALL, CLEAR SIGNS OF STRESS SHIELDING WERE OBSERVED FOR BOTH CSRAS DESIGNS IN THE IN-VITRO FEA AND HUMAN RETRIEVAL ANALYSIS. ESPECIALLY IN THE CENTRAL PART OF BOTH IMPLANT DESIGNS THE BONE STOCK WAS HIGHLY RESORBED. THE IMPACT OF THESE BONE REMODELLING PROCESSES ON THE CLINICAL OUTCOME AS WELL AS LONG-TERM STABILITY REQUIRES FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658989 UNKNOWN COPELAND SHOULDER PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R