BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X20 ST

    MDR report key: 7524374 · Received May 17, 2018

    Report

    Report Number
    0001825034-2018-03160
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    September 21, 2015
    Report Date
    June 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 731520; 180557, COMP NLK SCR 3.5HEX 4.75X15 ST, 452670; 115382, COMP RVS CNTRL SCR 6.5X30MM ST, 877000; 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 246500; 115370, COMP RVS TRAY CO 44MM, 848480; 113618, COMP PRIMARY STEM 18MM MICRO, 661170; XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 478500; 405889, COMP RVS 2.7MM DIA DRL, 055780; 115310, COMP RVRS SHLDR GLNSP STD 36MM, 933470; 180557, COMP NLK SCR 3.5HEX 4.75X15 ST, 452670; 405800, COMP. REV SHLDR 9 IN STEINMANN, 132910; 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 731520; 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 664220; 405883, COMP RVS 3.2MM DRL, 04_310; CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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 - 2018 - 03159; 0001825034 - 2018 - 03161; 0001825034 - 2018 - 02448; 0001825034 - 2018 - 02449.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A CENTRAL SCREW FRACTURE, A LOOSE GLENOSPHERE, AND SCREW MIGRATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A CENTRAL SCREW FRACTURE AND A LOOSE, DISASSOCIATED GLENOSPHERE. DURING THE REVISION, IT WAS FOUND THAT THE SCREWS HAD MIGRATED AND CUT OUT THE POSTERIOR GLENOID. THE PATIENT WAS CONVERTED TO A HEMI-ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366038 COMP LK SCR 3.5HEX 4.75X20 ST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 664220 

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R