BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COPELAND RESURFACING SHOULDER

    MDR report key: 6969880 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09514
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT/ITEM 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, UNDER WARNINGS: INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. LITERATURE: RAI, PAUL, DAVIES, OWAIN, WAND, JON & BIGSBY, EWAN. (2015) LONG-TERM FOLLOW UP OF THE COPELAND MARK III SHOULDER RESURFACING HEMI-ARTHROPLASTY. JOURNAL OF OTHOPAEDICS. JOR-190; NO. OF PAGES 5. 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. ZIMMER BIOMET COMPLAINT(B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A REVIEW OF A JOURNAL ARTICLE TITLED, "LONG-TERM FOLLOW-UP OF THE COPELAND MARK III SHOULDER RESURFACING HEMIARTHROPLASTY". REVIEW OF ARTICLE IDENTIFIED A FEMALE PATIENT, NOW DECEASED (NOT IMPLANT RELATED), THAT SUFFERED A PERIPROSTHETIC FRACTURE AFTER A FALL, 3 YEARS AND 11 MONTHS AFTER HER ORIGINAL SURGERY. THIS FRACTURE SUCCESSFULLY HEALED AFTER FIXATION WITH A HUMERAL LOCKING PLATE. THERE WERE NO NERVE INJURIES, INFECTIONS OR DISLOCATIONS IN THIS COHORT. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748069 UNKNOWN COPELAND RESURFACING SHOULDER PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R