BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS NAIL CAP, 0MM

    MDR report key: 22169783 · Received June 9, 2025

    Report

    Report Number
    0009613350-2025-00411
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 17, 2024
    Report Date
    October 28, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505704
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. PROXIMAL HUMERUS, LEFT, LONG, ÿ 7X220MM ITEM# 47249622107, LOT# 3127391 BLUNT TIP SCREW, ÿ 4X34MM ITEM# 47248603440, LOT# 3091296. BLUNT TIP SCREW, ÿ 4X34MM ITEM# 47248603440, LOT# 3091447. CORTICAL BONE SCREW, ÿ 4X20MM ITEM# 47248612040, LOT# 3126149. CORTICAL BONE SCREW, ÿ 4X22MM ITEM# 47248612240, LOT# 3152713. G2. REPORT SOURCE: SPAIN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A3, B3, B4, B5, B7, D6B, G3, G6, H2, H6, H10, H11.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H11. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THAT THE REPORTED EVENT WAS UNRELATED TO THE REPORTED ZB DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE WITH AFFIXUS HUMERAL NAIL SYSTEM. SUBSEQUENTLY, EXPERIENCED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS AND APPROXIMATELY ONE YEAR POST IMPLANTATION UNDERWENT A REVISION SURGERY WHEN THE DEVICE WAS REMOVED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL ORIF OF THE LEFT HUMERUS. SUBSEQUENTLY, THE SITE REPORTED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS. THE PATIENT UNDERWENT HARDWARE REMOVAL, APPROXIMATELY 10 MONTHS POST IMPLANTATION, WITH REPAIR OF A PARTIAL ROTATOR CUFF INJURY. NO COMPLICATIONS OR ALLEGATIONS AGAINST HARDWARE WERE REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS IT WAS CONFIRMED THAT THE REPORTED EVENT WAS UNRELATED TO THE REPORTED ZB DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344436 PROXIMAL HUMERUS NAIL CAP, 0MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3151018 00889024505704

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| R SEE H11 NARRATIVE.