BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 7346902 · Received March 16, 2018

    Report

    Report Number
    0001825034-2018-01966
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Report Date
    April 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 040280. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001825034-2018-01967.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE TRAY AND BEARING WERE RETURNED FOR EVALUATION. THE TRAY AND BEARING ARE VISUALLY CONFORMING TO THE PRINT. THERE ARE NO BURRS OR OBSTRUCTIONS IN THE RINGLOC GROOVE. DIMENSIONAL ANALYSIS PERFORMED ON THE RING SHOW THAT IT WAS CONFORMING TO SPECIFICATIONS. THERE ARE SIGNS OF DAMAGE TO THE BEARING WHERE IT WAS IMPACTED AGAINST THE RING. THE RING IS BENT NEAR THE RELIEF CUT. THIS COULD BE FROM THE ASSEMBLY ATTEMPT DURING THE PROCEDURE, BUT WITHOUT BEING PRESENT AT THE TIME OF THE PROCEDURE IT IS IMPOSSIBLE TO CONFIRM WHEN THE RING WAS BENT. SINCE PROPER SURGICAL TECHNIQUE WAS FOLLOWED AND PRODUCTS WERE CONFORMING TO SPECIFICATIONS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE ASSEMBLY ISSUE. DHR (DEVICE HISTORY RECORDS) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED NO FURTHER ACTION(S) IS/ARE REQUIRED. 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 WAS REPORTED THAT THE POLY DID NOT SEAT AND WAS WASTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188597 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 060790

    Patients

    Seq Age Sex Outcome Treatment
    1