BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 8757654 · Received July 3, 2019

    Report

    Report Number
    0001825034-2019-02683
    Event Type
    Injury
    Date Received
    July 3, 2019
    Report Date
    November 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE MALFUNCTION, SERIOUS INJURY, OR ADVERSE EVENT. PLEASE VOID THIS SUBMISSION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI : (B)(4). CONCOMITANT MEDICAL PRODUCTS : DEVICE REVISED AT FIRST STAGE OF REVISION (B)(6) 2018: GLENOSPHERE 115310 222460 2027-08-18, MINI BASEPLATE 01000589 LOT:357320 2028-01-09, FIXED SCREW 180551 LOT: 455490 2026-03-21, NON-LOCKING SCREW 180557 LOT 217280 2027-09-11, NON-LOCKING SCREWS 180558 LOT:860890 2027-08-20, FIXED SCREW 180550 LOT 494250 2027-05-15, CENTRAL SCREW 115394 LOT 572030 2027- 10-17. DEVICES NOT REVISED; WILL BE REVISED IN STAGE 2. TAPER ADAPTOR 115310 LOT:222460 EXP 2027-08-18, MINISTEM 113632 LOT:300720 2027-10-18, HUMERAL BEARING XL115363 LOT 503500 2022-10-31, HUMERAL TRAY 9707938-00 LOT 17013429 2018-10.

    Description of Event or Problem · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE MALFUNCTION, SERIOUS INJURY, OR ADVERSE EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAS HAD STAGE ONE OF A TWO STAGE REVISION TO ADDRESS GLENOID IMPLANT RELATED BONE LOSS. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION TO ADDRESS GLENOID IMPLANT RELATED BONE LOSS AND EROSION. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552046 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 222460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other