BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL

    MDR report key: 18827683 · Received March 4, 2024

    Report

    Report Number
    0001825034-2024-00612
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    April 1, 2019
    Report Date
    May 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475519
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE THE ASSOCIATED REPORTS: 0001825034-2024-00599, 0001825034-2024-00600, 0001825034-2024-00613, AND 0001825034-2024-00614. D10: CONCOMITANT MEDICAL PRODUCTS, PART NUMBER (LOT NUMBER): 115345 (282340), TI-115310 (404450), 113648 (612050), AND 010000589 (303250). ASSOCIATED PRODUCT INFORMATION: 115396 (919970), 180550 (719630), 180551 (303600), 32-486265 (231570), 405800 (336750), 405883 (544160), 405889 (332830), 98000900020, 98B00900120, AND 98B00901107. E1: FULL ESTABLISHMENT NAME: (B)(6) HOSPITAL. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION TO E1 ZIP CODE. D10: CONCOMITANT MEDICAL PRODUCTS, PART NUMBER (LOT NUMBER); REPORT NUMBER: 115345 (282340); 0001825034-2024-00599. TI-115310 (404450); 0001825034-2024-00600. 113648 (612050); 0001825034-2024-00613. 010000589 (303250); 0001825034-2024-00614. 115396 (919970). 180550 (719630). 180550 (719630). 180551 (303600). ASSOCIATED PRODUCT INFORMATION: 32-486265 (231570). 405800 (336750). 405883 (544160). 405889 (332830). 98000900020 (UNKNOWN). 98B00900120 (UNKNOWN). 98B00901107 (UNKNOWN). THE REPORTED EVENT OF REVISION HAS BEEN CONFIRMED THROUGH MEDICAL RECORDS. HOWEVER, THE REASON FOR THE REVISION WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL NOTES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED A RIGHT SHOULDER REVISION ARTHROPLASTY WITH NICKEL-FREE PROSTHESIS AND AN ENTIRE PROXIMAL HUMERUS ALLOGRAFT. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A STAGE-TWO REVISION RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. THE PATIENT UNDERWENT AN ADDITIONAL REVISION WITH A NICKEL FREE PROSTHESIS SIX (6) MONTHS AFTER THE REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710613 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOMXL SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 358590 00880304475519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R H10.| H11.