BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR POROUS HUMERAL PROSTHESIS 11.0MM STEM

    MDR report key: 6714830 · Received July 14, 2017

    Report

    Report Number
    0001825034-2017-04964
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    June 19, 2017
    Report Date
    November 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK992119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    XRAYS WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. X-RAYS WERE RECEIVED AND REVIEWED. THE RESULTS IDENTIFIED: "THE HUMERAL COMPONENT IS HIGH-RIDING WITH NEAR COMPLETE LOSS OF THE SUBACROMIAL SPACE. THIS IS ALMOST CERTAINLY DUE TO FULL THICKNESS AND MORE THAN LIKELY FULL WIDTH ROTATOR CUFF TEAR. THE HARDWARE IS INTACT AND NORMALLY POSITIONED WITHOUT SURROUNDING LUCENCIES. THE BONES DEMONSTRATE NO ACUTE FRACTURE." ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). MEDICAL PRODUCTS- HUMERAL HEAD CATALOG #: UNK LOT #: UNK, TAPER CATALOG #: UNK LOT #: UNK, GLENOID COMPONENT CATALOG #: UNK LOT #: UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04946, 0001825034-2017-04963, 0001825034-2017-04965.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SPECIFIC IMPLANT DATE IS UNKNOWN, HOWEVER IT OCCURRED IN THE YEAR OF 1998. CONCOMITANT MEDICAL PRODUCTS-HUMERAL HEAD CATALOG#: 113764 LOT#: 751260, GLENOID CATALOG#: 113856 LOT#: 322210, 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 IS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION DUE TO ROTATOR CUFF DEFICIENCY. COMPONENTS WERE REMOVED AND REPLACED WITH A REVERSE TOTAL SHOULDER ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494744 BIO-MODULAR POROUS HUMERAL PROSTHESIS 11.0MM STEM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 676930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R REFERENCE H10