BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVERS/REVERS SCR SYST 4.5-36

    MDR report key: 22020005 · Received May 14, 2025

    Report

    Report Number
    0009613350-2025-00373
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 14, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    PHX
    UDI-DI
    00889024483040
    PMA / PMN Number
    K052906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: INVERS/REVERS SCR, #ITEM: 0104223036, #LOT: 2823876. TM RVS BASE PLT, #ITEM: 00-4349-015-00, #LOT: 63799890. 36MM VIT E LINER +0MM, #ITEM: 00-4350-036-00, #LOT: 64054234. THERAPY DATE : (B)(6) 2025. G2: FOREIGN REPORT SOURCE JAPAN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT (B)(4). UPDATED:B4,B5,D2,G1,G3,G6,H1,H2,H3,H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE THE INFORMATION PROVIDED FOR THIS REPORTED EVENT REFERS A TENDENCY OF DISLOCATION OF THE SHOULDER IMPLANT AND PAIN. THE SCREWS REPORTED IN THIS COMPLAINT ARE NOT INVOLVED IN THE DISLOCATION EVENT, BUT THEIR INVOLVEMENT IN THE ONSET OF PAIN CANNOT BE EXCLUDED. BASED ON THE AVAILABLE INFORMATION, A RELATION BETWEEN THE ONSET OF PAIN AND THE INVOLVEMENT OF THE SCREW CANNOT BE CONFIRMED, AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE ESTABLISHED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO PAIN AND TMR LOOSENING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216675 INVERS/REVERS SCR SYST 4.5-36 IMPLANT, TRAUMA PHX ZIMMER GMBH 2937875 00889024483040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.