BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC HD ARCOM XL 28X38MM

    MDR report key: 8653839 · Received May 30, 2019

    Report

    Report Number
    0001825034-2019-02356
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    March 26, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SUPERIOR AND POSTERIOR DISLOCATION OF THE LEFT FEMORAL HEAD. SCLEROSIS OF THE RIGHT FEMORAL HEAD SUGGEST POSSIBLE AVN. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE DUAL MOBILITY HEAD AND BEARING BECAME DISASSOCIATED LEADING TO REVISION OF THE COMPONENTS. LARGE HEMATOMA NOTED WITH DISSOCIATION BETWEEN THE 2 FEMORAL HEADS WITH DUAL MOBILITY COMPONENT. STEM NOTED TO BE WELL INGROWN WELL FIXED AND WELL POSITIONED. DISSOCIATED POLY FEMORAL HEAD NOTED AND REMOVED WITHOUT INJURY. NO SIGNS OF DAMAGE NOTED ON THE METAL LINER. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS & MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE APPROXIMATELY THREE YEARS POST-INITIAL. DURING THE REDUCTION IT WAS NOTED THAT THE DUAL MOBILITY HEAD AND BEARING HAD DISASSOCIATED LEADING TO THE REVISION TWO DAYS POST CLOSED REDUCTION. DURING THE REVISION PROCEDURE A LARGE HEMATOMA WAS NOTED WITH DISASSOCIATION BETWEEN THE TWO FEMORAL HEADS WITH DUAL MOBILITY COMPONENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 00625006535, LOT NUMBER: 64190171, BRAND NAME: BONE SCREW; CATALOG NUMBER:00625006525, LOT NUMBER: 64124990, BRAND NAME: BONE SCREW; CATALOG NUMBER: 00877502802, LOT NUMBER: 2960402, BRAND NAME: BIOLOX DELTA CERAMIC HEAD; CATALOG NUMBER: 010000661, LOT NUMBER: 3442540, BRAND NAME: G7 ACETABULAR SHELL; CATALOG NUMBER:110024461, LOT NUMBER: 599730, BRAND NAME: G7 DUAL MOBILITY; CATALOG NUMBER: 00771100910, LOT NUMBER: 63994695, BRAND NAME: M/L TPER STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FALL AND UNDERWENT A CLOSED REDUCTION, DURING THE REDUCTION, IT WAS NOTED THAT THE DUAL MOBILITY HEAD AND BEARING BECAME DISASSOCIATED LEADING TO REVISION OF THE COMPONENTS. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449267 ACT ARTIC HD ARCOM XL 28X38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 332220

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R