BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING AR COM XL

    MDR report key: 6994254 · Received November 1, 2017

    Report

    Report Number
    0001825034-2017-09812
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 9, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVS TRAY CO 44MM LOT#652190 ITEM#115370, COMP PRIMARY STEM 11MM MINI LOT#546700 ITEM#113631, COMP LK SCR 3.5HEX 4.75X30 ST LOT# 061500 ITEM#180553 , COMP LK SCR 3.5HEX 4.75X20 ST LOT#817520 ITEM#180551, COMP RVRS SHLDR GLNSP STD 36MM LOT#343450 ITEM#115310, COMP NLK SCR 3.5HEX 4.75X25 ST LOT#820720 ITEM#180559, COMP RVRS 25MM BSPLT HA+ADPTR LOT#996420 ITEM#010000589, COMP RVS CNTRL 6.5X40MM ST/RST LOT#991060 ITEM# 115398, COMP. REV SHLDR 9 IN STEINMANN LOT#871200 ITEM# 405800. THE REPORTED IS CONFIRMED AS THE VISUAL INSPECTION OF THE RETURNED PRODUCTS REVEALED THAT THE LOCKING RING WAS BENT AND THE POLY SHOWED SCRATCHES. THE MARKING/IDENTIFICATION WAS ALSO ILLEGIBLE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. COMPATIBILITY CHECK NOTED NO ISSUES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INDICATED THAT THE 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: 0001825034-2017-09811, 0001825034-2017-09812.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED A PROBLEM ASSEMBLING THE HUMERAL BEARING WITH THE BASEPLATE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY. AS A RESULT, THE POLY EXPERIENCED DAMAGE NEAR THE LOCKING MECHANISM OF THE BASEPLATE AND THE LOCKING RING EXPERIENCED DAMAGE AS WELL. FOLLOWING A 5 MINUTE DELAY, THE SURGEON OPENED NEW COMPONENTS AND EXPERIENCED NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773923 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING AR COM XL PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 812440

    Patients

    Seq Age Sex Outcome Treatment
    1