BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. CORTICAL LOCKING SCREW 3.5 MM X 34 MM

    MDR report key: 22330712 · Received June 25, 2025

    Report

    Report Number
    0001825034-2025-01850
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    July 31, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    UDI-DI
    00887868351921
    PMA / PMN Number
    K143697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. - D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - 110025444(926313) - 110025446(926314) - 110025450(926294) - 110025450(926294) - 110025458(61271120) - 856135026(65686246) - 856135028(66204732) - 856135028(66421922) - 856135044(65686792) - 856135046(65686836) - G2: FOREIGN - THE EVENT OCCURRED IN JAPAN THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION (REMAINS IMPLANTED IN THE PATIENT). 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1; B2; H1; H6. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D9; G1; G3; G6; H2; H3; H6; H10. THE REPORTED EVENT IS CONFIRMED VIA MEDICAL REVIEW. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LATERAL PLATE AND SCREW FIXATION DEVICE OF THE RIGHT SHOULDER WITH POSSIBLE PARTIAL WITHDRAWAL OF THE LATERAL PLATE DISTALLY IN THE INTERVAL. OVERALL FIT AND ALIGNMENT OF THE IMPLANT IS APPROPRIATE TWO MONTHS POSTOP. THERE DOES APPEAR TO BE PARTIAL WITHDRAWAL OF THE DISTAL PLATE NOTED ON THE 3.5 MONTH IMAGES WHICH IS NEW IN THE INTERVAL. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY FOUR (4) MONTHS AFTER A SHOULDER PROCEDURE, THE PLATING SYSTEM MIGRATED FROM ITS INTENDED POSITION AND THE DISTAL PORTION OF THE PLATE MAY HAVE LIFTED. NO REVISION SURGERY IS PLANNED AT THIS TIME. 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
    1130182 A.L.P.S. CORTICAL LOCKING SCREW 3.5 MM X 34 MM PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. 65686547 00887868351921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11