BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASE PLATE 15 MM POST LENGTH UNCEMENTED

    MDR report key: 12598881 · Received October 8, 2021

    Report

    Report Number
    0001822565-2021-02884
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    March 25, 2021
    Report Date
    October 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00889024268999
    PMA / PMN Number
    K130661
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:: 00434903611 64463135 GLENOSPHERE 36 MM DIAMETER. 0104211123 3015699 ANATOMICAL SHOULDER¿¢, HUMERAL STEM, CEMENTED, ø 12, 100 MM. 0104223100 3032165 ANATOMICAL SHOULDER¿¢ REVERSE, HUMERAL CUP, 0°, RETRO. UNK STEM EXTREMITIES IMPL. FOREIGN COUNTRY: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THERE IS ABNORMAL SLIGHTLY INCREASED SPACING INFERIORLY BETWEEN THE BASE PLATE IN THE GLENOSPHERE WHEN COMPARED TO THE SPACING MORE SUPERIORLY. THIS COULD BE RELATED TO SEVERAL POSSIBILITIES, INCLUDING BUT NOT LIMITED TO INSTABILITY OF THE BASE PLATE (FRACTURE AS REPORTED), IMPROPER INTEGRATION OF THE HARDWARE COMPONENTS, OR IMPROPERLY POSITIONED COMPONENTS UPON IMPLANTATION. NO RADIOGRAPHIC SIGNS OF LOOSENING. REMAINDER OF THE HARDWARE APPEARS INTACT AND WELL INTEGRATED WITHOUT PERIPROSTHETIC LUCENCIES. BONES ARE INTACT WITHOUT FRACTURE. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED THE TM REVERSE SHOULDER BASE PLATE HAD DAMAGE ON THE TAPER, AND THE ZIMMER TM REVERSE SHOULDER GLENOSPHERE SHOWED DAMAGE/SCRATCHES ON THE OUTER SURFACE. THE CONICAL TAPER EXHIBITED NO DAMAGE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2021 - 02885.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO POSSIBLE INSTABILITY, DISASSOCIATION, IMPLANT FRACTURE AND IMPROPER INTEGRATION. DURING THE REMOVAL, IT WAS REPORTED THE GLENOID HAD LOOSENED OR WAS IMPROPERLY POSITIONED. WHEN THE SURGEON INSERTED THE HUMERAL PLATE, HE HAD TO USE A LOT OF TENSION AND STRENGTH. AS A RESULT, IT MAY HAVE HAPPENED THAT HE USED THE LEVERS TO PUSH THE GLENOSPHERE BACK OFF. THE BASE PLATE HAS ALSO BROKEN OUT. THERE WAS NO MENTION OF A TRAUMATIC EVENT. IN ADDITION, THE HUMERAL SHELL COULD NOT BE SEPARATED FROM THE SHAFT. CEMENT GOT INTO THE GAP BETWEEN THE SHAFT AND THE CONE. THE CEMENTED STEM WAS EXPLANTED WITH THE SHELL. ABNORMAL SPACING IS SEEN ON X-RAYS RECEIVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496574 BASE PLATE 15 MM POST LENGTH UNCEMENTED PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 64612803 00889024268999

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R