BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE REVERSE E1 44-36 STD HMRL BRNG

    MDR report key: 8151509 · Received December 11, 2018

    Report

    Report Number
    0001825034-2018-11070
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 15, 2018
    Report Date
    April 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    K113121
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE TRAY, BEARING AND LOCK RING WERE RETURNED FOR EVALUATION. DIMENSIONAL ANALYSIS OF THE LOCK RING IS CONFORMING. THE RING IS OBSERVED TO BE BENT. IT IS UNKNOWN IF THIS OCCURRED WHILE ATTEMPTING TO IMPACT THE LINER OR FROM DISASSEMBLING THE RING FROM THE TRAY. THE RING-LOC GROOVE IS FREE OF BURRS. THERE IS DAMAGE TO THE BEARING FROM IMPACTION. IN THE RETURNED CONDITION, THE BEARING CANNOT BE ASSEMBLED TO THE TRAY. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN - (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCT: 115340 COMP RVS HMRL TI TRAY 44MM, 252440. THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11071.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, THE HUMERAL BEARING WOULD NOT SEAT PROPERLY IN THE HUMERAL TRAY. NEW IMPLANTS WERE USED TO COMPLETE THE SURGERY. NO PATIENT INJURY OR DELAY IN SURGERY WAS NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991585 COMPREHENSIVE REVERSE E1 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 157730

    Patients

    Seq Age Sex Outcome Treatment
    1