BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 7320572 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01715
    Event Type
    Injury
    Date Received
    March 7, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: PN 180502 SCREW LN 696450; PN 180501 SCREW LN 609520; UNKNOWN HUMERAL STEM; UNKNOWN BASEPLATE; UNKNOWN TAPER; PN 115310 COMP RVRS SHLDR GLNS LN 081870 ; PN 115370 COMP RVS TRAY LN 287370. 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 AS NO WERE TRENDS IDENTIFIED. 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

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE HUMERAL TRAY, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE STEM, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE TAPER, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE GLENOID BASEPLATE, UNKNOWN. 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 - 01714, 0001825034 - 2018 - 01713, 0001825034 - 2018 - 01716, 0001825034 - 2018 - 01717, 0001825034 - 2018 - 01718.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 115340, COMP RVS HMRL TI TRAY 44MM, UNKNOWN; 115310, COMP RVRS SHLDR GLNSP STD 36MM, UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE EXCRUCIATING PAIN AND LOSS OF FUNCTION THREE MONTHS AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164173 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 828610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other