BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASEPLATE, S, 15MM

    MDR report key: 20451033 · Received October 15, 2024

    Report

    Report Number
    0009613350-2024-00487
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    June 20, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    PHX
    UDI-DI
    00889024490314
    PMA / PMN Number
    K193099
    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): G2: REPORT SOURCE JAPAN. D10: ITEM # 0104440012, LINER, S, LOT # 2993054; ITEM # TN190-127-90, OSC BLD 19X1.27X90, LOT # 1055949; ITEM # 110003484, ACCESS 3.2MM THD STEINMANN 9, LOT # 285220; ITEM # 115738, COMPR NANO HMRL PPS 38MM, LOT # 171050; ITEM # 0104440018, DPSC SCREW, 18MM, LOT # 3010122; ITEM # 0104440027, DPSC SCREW, 27MM, LOT # 2996243; ITEM # 113134, VERSADIAL 42X21X43 HUM HD CAST, LOT # 066950; ITEM # 118001, VERSA-DIAL/COMP TI STD TAPER LOT # 399140; ITEM # 31-406990, COMPR NANO 7IN STEINMANN PIN LOT # 447980. NO PRODUCTS WERE RETURNED TO THE POST MARKET SURVEILLANCE TEAM FOR EXAMINATION. HOWEVER, ONE IMAGE WAS PROVIDED SHOWING THE EXPLANTED GLENOID COMPONENTS. THE ANAVERSE LINER CAN BE SEEN DETACHED FROM THE BASEPLATE, COVERED IN BLACK RESIDUE. THE LINER DOES NOT APPEAR DEFORMED, BUT THE SNAP FITS CAN BE SEEN TO BE WORN OUT. THE ANAVERSE BASEPLATE HAS FRACTURED ALONG THE RIM, WHICH THE FRAGMENT BEING SEEN IN THE PROVIDED IMAGE. THE BASEPLATE ALSO APPEARS TO BE WORN. THE TM CENTRAL PEG OF THE BASEPLATE IS NOT SHOWN ON THE IMAGE. ADDITIONALLY, TWO SCREWS CAN BE SEEN IN THE IMAGE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. THE RELEVANT DIMENSIONS OF THE LINER (E.G DIMENSIONS AND DISTANCE OF SNAPS) OF ALL 24 MANUFACTURED PARTS OF LOT 2993054 WERE MEASURED WITH THE COORDINATE MEASURING MACHINE AND FOUND TO BE WITHIN THE PRE-DEFINED TOLERANCE RANGE. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE SEQUENCE OF EVENTS LEADING UP TO THE REVISION SURGERY CANNOT BE DETERMINED. IT IS UNCLEAR WHETHER THE FRACTURE LED TO THE DISSOCIATION OF THE LINER OR IF THE DISSOCIATION RESULTED IN THE FRACTURE. ADDITIONALLY, IT IS UNCLEAR TO WHAT EXTENT THE REPORTED EVENT OF "HUMERAL HEAD [BEING] HEAVILY PRESSURIZED" CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS A PRECAUTIONARY MEASURE IT WAS DECIDED TO REMOVE THE ANAVERSE GLENOID LINERS FROM THE MARKET. AFTER SIX MONTHS A FOLLOW-UP LETTER WAS SENT IN ORDER TO PROVIDE THE CURRENT RATE OF POST-OPERATIVE DISASSOCIATION, AN UPDATE ON THE INVESTIGATION, AND ADDITIONAL INFORMATION WHEN TREATING PATIENTS WHO RECEIVED THIS PRODUCT. IT IS RECOMMENDED TO ENSURE REGULAR FOLLOW-UP WITH ALL PATIENTS WHO HAVE THE ANAVERSE GLENOID PE LINER IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY APPROXIMATELY 4 YEARS AFTER IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOID BASEPLATE FROM THE LINER. UPON REMOVAL IT WAS ALSO FOUND THAT THE BASEPLATE WAS FRACTURED. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED WITH COMPREHENSIVE REVERSE SHOULDER SYSTEM. THE PATIENT MATCHED IMPLANT REQUEST REPORTED INITIALLY FOR THIS CASE THAT WAS NO LONGER NEEDED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319597 BASEPLATE, S, 15MM SHOULDER PROTHESIS PHX ZIMMER GMBH N/A 3019007 00889024490314

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Hospitalization| R