BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 6996258 · Received November 2, 2017

    Report

    Report Number
    0001825034-2017-09352
    Event Type
    Injury
    Date Received
    November 2, 2017
    Report Date
    March 9, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-09353, 0001825034-2017-09354. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PART/LOT, GLENOSPHERE. UNKNOWN PART/LOT, BEARING. UNKNOWN PART/LOT, TAPER ADAPTOR. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: XL-115363 ARCOM XL 44-36 STD HMRL BRNG 812220, 115397 COMP RVS CNTRL 6.5X35MM ST/RST 519690, 405889 COMP RVS 2.7MM DIA DRL 905720, 405800 COMP. REV SHLDR 9 IN STEINMANN 538340, 405883 COMP RVS 3.2MM DRL 538650, 180551 COMP LK SCR 3.5HEX 4.75X20 ST 747090, 180559 COMP NLK SCR 3.5HEX 4.75X25 ST 723080, 180560 COMP NLK SCR 3.5HEX 4.75X30 ST 118230, 180560 COMP NLK SCR 3.5HEX 4.75X30 ST 285340, 118001 VERSA-DIAL/COMP TI STD TAPER 457290, 115330 COMP RVRS SHDR GLEN BSPLT +HA 519880, 113653 COMP PRIMARY STEM 13MM STD 193040, 115370 COMP RVS TRAY CO 44MM 057600. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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

    THE PATIENT REPORTED A LACK OF RANGE OF MOTION, PAIN, SUBLUXATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HEARD A NOISE IN THE IMPLANTED SHOULDER WHILE DRIVING. PATIENT'S SURGEON REVIEWED X-RAYS AND FOUND NO ISSUE WITH THE DEVICE. PATIENT REPORTED ALSO EXPERIENCING SUBLUXATION, PAIN, NUMBNESS IN FINGERS, AND LACK OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775404 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, EXTREMITY KWS ZIMMER BIOMET, INC. N/A 869230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other