BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 22336167 · Received June 26, 2025

    Report

    Report Number
    0009613350-2025-00453
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    October 9, 2024
    Report Date
    July 15, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: BASE PLATE UNCEMENTED, #ITEM 00436202000, #LOT 66175005, SIZE 12 STANDARD HUMERAL STEM, #ITEM SAHS1112, #LOT 66153482, -6MM EXTENDED NEUTRAL HUMERAL TRAY, #ITEM SAHTNEM6, #LOT 66274806, STANDARD 40MM DIAMETER BEARING, #ITEM 110031421, #LOT 65856757, GLENOSPHERE CENTRIC, #ITEM 00436004000, #LOT 65829320. THERAPY DATE: (B)(6) 2024. 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: CORRECTED: H5 - HEALTH EFFECT - CLINICAL CODE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ON (B)(6) 2024, SUBJECT RETURNED TO CLINIC DUE TO SHOULDER PAIN. AN MRI DEMONSTRATED A STRESS FRACTURE IN THE BONE LATERAL TO THE GLENOID. ON (B)(6) 2024 X-RAYS DEMONSTRATED DISPLACED ACROMIAL STRESS FRACTURE, PATIENT WORE SLING AND BEGAN PHYSICAL THERAPY. ON (B)(6) 2025 PATIENT RETURNS FOR FOLLOW-UP, PAIN HAS BEEN WELL CONTROLLED. XRAYS DEMONSTRATE A STABLE RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH A DISPLACED BUT STABLE ACROMIAL STRESS FRACTURE. PLAN TO CONTINUE ROUTINE POST-OP REHAB AND ACTIVITIES AS TOLERATED, WILL FOLLOW-UP IN 3MO FOR ADDITIONAL IMAGING. THE REPORTED EVENT IS CONFIRMED BY PROVIDED MEDICAL RECORDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 A PATIENT UNDERWENT AN INITIAL RIGHT PRIMARY REVERSE TOTAL SHOULDER PROCEDURE, APPROXIMATELY 10 MONTHS POST-OPERATIVELY, THE PATIENT RETURNED TO CLINIC FOR EVALUATION OF PAIN. UPON COMPLETION OF IMAGING A STRESS FRACTURE LATERAL TO THE GLENOID WAS DEMONSTRATED. THE PATIENT WORE A SLING FOR IMMOBILIZATION FOR 4 WEEKS, FOLLOWED BY ADDITIONAL PHYSICAL THERAPY FOR MOVEMENT AND STRENGTHENING, AND THE EVENT IS REPORTED TO BE RESOLVING. UPON 1 YEAR FOLLOW-UP A NORMAL RADIOGRAPHIC EVALUATION WAS NOTED ALONG WITH SLIGHT DIFFICULTY WITH ACTIVITIES AND SLIGHT PAIN REPORTED. ALL INITIAL PRODUCTS REMAIN IMPLANTED AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530496 UNKNOWN SCREW IMPLANT, TRAUMA LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H11 NARRATIVE