BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS IC SEG - 30MM

    MDR report key: 7306140 · Received March 1, 2018

    Report

    Report Number
    0001825034-2018-01409
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    April 15, 2014
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 211237, COMPR SRS MOD STEM - 10X100MM, 119270. 211253, COMPR SRS 50MM DST HML BDY RT, 494170. UNKNOWN, UNKNOWN DISCOVERY ULNA, UNKNOWN. UNKNOWN, UNKNOWN DISCOVERY HUMERAL CONDYLE KIT, UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. X-RAYS WERE SUBMITTED TO MMI FOR REVIEW. EVALUATION IS LIMITED BUT OVERALL THICKENED ALIGNMENT OF THE IMPLANTS APPEARS TO BE APPROPRIATE. BONE QUALITY SUGGESTS OSTEOPENIA. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. CONTRIBUTING FACTORS TO THE PAIN COULD BE THE OSTEOPOROSIS AND RHEUMATOID ARTHRITIS. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01410, 0001825034 - 2018 - 01411, 0001825034 - 2018 - 01412, 0001825034 - 2018 - 01413, 0001825034 - 2018 - 01414. CONCOMITANT MEDICAL PRODUCTS: 211224 COMPR SRS IC SEG - 30MM, UNKNOWN LOT, 211237 COMPR SRS MOD STEM - 10X100MM, UNKNOWN LOT, 211253 COMPR SRS 50MM DST HML BDY RT, UNKNOWN LOT, UNKNOWN PART/LOT; PROXIMAL BODY, REGENERX AUGMENT, PPS AUGMENT, SEAS AUGMENT. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN THE (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE 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. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FOUND IT SEVERELY DIFFICULT TO OPEN JAR, DO HEAVY CHORES, CARRY BAG, WASH BACK, CUT GRASS, PERFORM SOCIAL ACTIVITIES, AND PERFORM DAILY ACTIVITIES. THE PATIENT EXPERIENCED MODERATE PAIN AND MODERATE TINGLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151533 COMPREHENSIVE SRS IC SEG - 30MM PROSTHESIS, ELBOW JDC ZIMMER BIOMET, INC. N/A 067950

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other