BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING

    MDR report key: 6547407 · Received May 5, 2017

    Report

    Report Number
    0001825034-2017-03046
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    March 31, 2017
    Report Date
    June 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). (B)(4). CONCOMITANT PRODUCTS: UPDATE: CATALOG #: 010000589, COMP RVRS 25MM BASEPLT HA+ADPTR, LOT # 357400. CATALOG #: 115380, 6.5MM COMP RVRS CENTRAL SCREW 20MM, LOT # 709840. CATALOG #: 180500, 4.7MM COMP RVRS FIXD LOCKING SCREW 15MM, LOT # 791190. CATALOG #: 180501, 4.7MM COMP RVRS FIXD LOCKING SCREW 20MM, LOT # 71794257. CATALOG #: 113627, COMPREHENSIVE PRIMARY STEM 7MM MINI, LOT # 137150. CATALOG #: 180502, 4.75MM COMP RVRS FIXD LOCKING SCREW 25MM, LOT # 934440. CATALOG #: 180501, 4.75MM COMP RVRS FIXD LOCKING SCREW 20MM, LOT # 293380. CATALOG #: 405883, COMP RVRS CENTRAL SCREW DRILL, LOT # 548210. CATALOG #: 405800, COMP RVRS 9 INCH STEINMANN PIN, LOT # 818010. CATALOG #: 405889, COMP RVRS PERIPHERAL SCREW DRILL, LOT # 817890. H3: CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03019, 03045, 03046.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED THROUGH REVIEW OF THE DEVICE HISTORY RECORDS AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE IDENTIFIED. A STERILIZATION RECORDS REVIEW WAS ALSO PERFORMED AND NO DISCREPANCIES WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO ACTIONS ARE REQUIRED AT THIS TIME. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. 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

    IT IS REPORTED PATIENT UNDERWENT A WASHOUT APPROXIMATELY THIRTEEN (13) MONTHS POST-IMPLANTATION OF A REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO INFECTION. SUBSEQUENTLY, THE PATIENT WAS REVISED THREE (3) DAYS FOLLOWING THE WASHOUT, DUE TO THE INFECTION. THE HUMERAL TRAY, BEARING, AND GLENOSPHERE WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. THE PATIENT WILL BE TREATED WITH REIMPLANTATION OF NEW IMPLANTS, ONCE THE INFECTION CLEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329886 COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 071990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R