BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 19420299 · Received May 29, 2024

    Report

    Report Number
    0001825034-2024-01419
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 1, 2019
    Report Date
    May 20, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K193373
    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 REFERENCED WITH APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. CONCOMITANT MEDICAL PRODUCTS, PART NUMBER (LOT NUMBER); REPORT NUMBER: 115345 (282340); 0001825034-2024-00599 TI-115310 (404450); 0001825034-2024-00600 XL-115365 (358590); 0001825034-2024-00612 113648 (612050); 0001825034-2024-00613 010000589 (303250); 0001825034-2024-00614 180550 (719630) 180550 (719630) 180551 (303600) ASSOCIATED PRODUCT INFORMATION: 32-486265 (231570) 405800 (336750) 405883 (544160) 405889 (332830) 98000900020 (UNKNOWN) 98B00900120 (UNKNOWN) 98B00901107 (UNKNOWN) FULL ESTABLISHMENT NAME - (B)(6) HOSPITAL 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838568 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 919970

    Patients

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