BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC REPLACEMENT HUMERAL TRAY RING

    MDR report key: 6841343 · Received September 5, 2017

    Report

    Report Number
    0001825034-2017-06942
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 3, 2017
    Report Date
    March 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: 115375 COMP RVS TRAY +5MM CO 44MM 029050, 106021 RINGLOC+ REPLACEMENT RING SZ21 772120, EP-115394 E1 44-36 STD +3 HMRL BRG 633410. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION REVEALED LOCKING RING WAS SEVERELY BENT AND DINGED; TRAY TAPER SCRATCHED; AND POLY HAD SLIGHT NICKS AND SCRATCHES. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT IMPLANT OR EXPLANTED. 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). MEDICAL PRODUCTS: COBALT CHROME +5 HUMERAL TRAY, PART # 115375, LOT # 029050. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017- 06941. IT IS UNKNOWN IF THE PRODUCT WILL 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING INITIAL REVERSE SHOULDER SURGERY, THE POLY WAS NOT ABLE TO ASSEMBLE WITH THE TRAY. EVEN AFTER TRYING TO USE A NEW LOCKING RING WITH THE POLY, STILL IT WON'T ASSEMBLE WITH THE TRAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622449 RINGLOC REPLACEMENT HUMERAL TRAY RING PROSTHESIS, SHOULDER LPH BIOMET ORTHOPEDICS N/A 772120

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other