BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER

    MDR report key: 4410815 · Received January 12, 2015

    Report

    Report Number
    0001825034-2015-00137
    Event Type
    Injury
    Date Received
    January 12, 2015
    Report Date
    October 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. INITIAL REPORTER -THE ARTICLE WAS WRITTEN BY BENJAMIN ALLEN, MD, BRADLEY SCHOCH, MD, JOHN W. SPERLING, MD, MBA, ROBERT H. COFIELD, MD; J SHOULDER ELBOW SURG (2014) 23, 214-220; JOURNAL OF SHOULDER AND ELBOW SURGERY BOARD OF TRUSTEES. HTTP://DX.DOI.ORG/10.1016/J.JSE.2013.05.012 IT IS LIKELY THAT THE COMPLICATIONS FOR THESE PATIENTS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED PATIENT INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE PATIENT COMPLICATIONS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SHOULDER ARTHROPLASTY FOR OSTEOARTHRITIS SECONDARY TO GLENOID DYSPLASIA: AN UPDATE" WHICH EXPLORES THE ROLE OF ANATOMIC SHOULDER ARTHROPLASTY (BOTH HEMIARTHROPLASTY AND TOTAL SHOULDER ARTHROPLASTY) IN TREATMENT OF GLENOID DYPLASIA WITH OSTEOARTHRITIS. THE STUDY WAS CONDUCTED BETWEEN 1980 AND 2008. TWENTY (20) PATIENTS UNDERWENT ANATOMIC SHOULDER ARTHROPLASTY (22 SHOULDERS) FOR TREATMENT OF OSTEOARTHRITIS SECONDARY TO GLENOID DYSPLASIA. THERE WERE EIGHT (8) HEMIARTHROPLASTIES AND FOURTEEN (14) TOTAL SHOULDER ARTHROPLASTIES. THE AVERAGE FOLLOW-UP WAS 6 YEARS. IT WAS REPORTED BY THE SURGEON THAT THE MAJORITY OF THE PATIENTS RECEIVED COMPETITOR COMPONENTS. THE JOURNAL ARTICLE REPORTS THAT REVISION PROCEDURES OCCURRED DUE TO THE FOLLOWING REASONS: THREE (3) REVISIONS DUE TO PAIN, TWO (2) REVISIONS DUE TO INFECTION, ONE (1) REVISION DUE TO WEAR OF THE POLYETHYLENE LINER, ONE (1)REVISION DUE TO GLENOID COMPONENT LOOSENING ONE (1) REVISION DUE TO AN UNKNOWN REASON. AT THE FOLLOW-UP, PAIN WAS RELIEVED IN 4 OF 8 SHOULDERS UNDERGOING HEMIARTHROPLASTY AND IN 10 OF 14 SHOULDERS UNDERGOING TOTAL ARTHROPLASTY. MEAN ACTIVE ELEVATION IMPROVED FROM 96 TO 125 , AND EXTERNAL ROTATION IMPROVED FROM 19 TO 42 . MOTION IMPROVEMENTS WERE SIMILAR FOR HEMIARTHROPLASTY AND TOTAL SHOULDER ARTHROPLASTY. IN CONCLUSION, FAVORABLE RESULTS CAN BE OBTAINED WITH THE USE OF ANATOMIC IMPLANTS IN THE TREATMENT OF GLENOID DYSPLASIA.

    Description of Event or Problem · 1

    MULTIPLE EVENTS WERE RECORDED UNDER A SINGLE RECORD. THIS REPORT WILL ADDRESS: ONE (1) REVISION DUE TO DEEP INFECTION INVOLVING THE "NEER" (BIOMET) COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27088 UNKNOWN SHOULDER PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention