BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE VERSA-DIAL HUMERAL HEAD

    MDR report key: 8070641 · Received November 14, 2018

    Report

    Report Number
    0001825034-2018-10668
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    July 31, 2018
    Report Date
    March 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    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 AND/OR CORRECTED INFORMATION. X-RAYS AND MEDICAL HISTORY OF THE PATIENT WERE REVIEWED AND THE REPORTED EVENT WAS NOT CONFIRMED. AS PER THE X-RAY REVIEW AND MEDICAL HISTORY, THERE WAS NO GLENOID RADIOLUCENCY, OSTEOLYSIS OR MIGRATION. ADDITIONALLY, THERE WAS NO HUMERAL RADIOLUCENCY, OSTEOLYSIS, MIGRATION, OR SUBSIDENCE. THERE WAS ALSO NO BONE FRACTURE OR SCAPULAR NOTCHING NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED HOWEVER, IT WAS NOTED THE PAIN OCCURRED AFTER PATIENT WAS SWIMMING WHICH MAY HAVE CONTRIBUTED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI - N/A CONCOMITANT MEDICAL PRODUCTS: 115734,COMPREHENSIVE NANO HUMERAL COMPONENT PPS, 488240; 118001,COMPREHENSIVE STANDARD TAPER ADAPTOR, 421740; 113952,MODULAR HYBRID GLENOID BASE, 215380; PT-113950,MODULAR HYBRID GLENOID POST¿REGENEREX, 053290. FOREIGN COUNTRY: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -10667, 0001825034 -2018 -10669, 0001825034 -2018 -10670. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD INITIAL LEFT COMPREHENSIVE ANATOMIC NANO ARTHROPLASTY. SUBSEQUENTLY, PATIENT BEGAN EXPERIENCING SEVERE PAIN AND LIMITED RANGE OF MOTION FOUR (4) YEARS POST INITIAL SURGERY. AN OPEN BICEPS TENOTOMY AND OPEN AC JOINT EXCISION WERE PERFORMED TO TREAT THE PAIN. OUTCOME OF TREATMENT IS PENDING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912008 COMPREHENSIVE VERSA-DIAL HUMERAL HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 559620

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R