BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN INVERSE REVERSE CANC 4.5*42 MM SCREW

    MDR report key: 9082073 · Received September 18, 2019

    Report

    Report Number
    0001822565-2019-04054
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE PRODUCT WAS REPORTED ON WRONG MFR NUMBER AND WILL BE REPORTED ON CORRECT MFR 9613350.

    Additional Manufacturer Narrative · 0

    (B)(4). 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

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE PRODUCT WAS REPORTED ON WRONG MFR NUMBER AND WILL BE REPORTED ON CORRECT MFR 9613350.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PRIOR REVISION TO THE LEFT TOTAL REVERSE ON APPROXIMATELY A YEAR AGO, AND NOW THE PATIENT IS BEING SCHEDULED FOR A REVISION DUE TO LUCENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI): N/A. CONCOMITANT MEDICAL PRODUCT: CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 795950; CATALOG #: 85225, TOTAL JOINT, LOT # 402282; CATALOG #: 81207, MUSCULOSKELETAL TRANSPLANT FND, SERIAL # (B)(4); CATALOG #: 132725, PLATE TM REVERSE BASE 25MM POS, LOT # 63685438; CATALOG #: 132713, LAT STABILIZING KNEE SUPP SM BLK, LOT # 2908167; CATALOG #: 132730, SPHERE GLENO TM, LOT # 53736824; CATALOG #: XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, LOT # 927530. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-04056. WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL LEFT SHOULDER IMPLANT APPROXIMATELY TWO 2 YEARS AGO. SUBSEQUENTLY THE PATIENT HAS BEEN INDICATED FOR A REVISION DUE TO LUCENCY FROM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878756 UNKNOWN INVERSE REVERSE CANC 4.5*42 MM SCREW FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 2908167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other