BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG

    MDR report key: 14485386 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00389
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 2013112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MARCH-2021. EXPIRATION DATE: 2026-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT. 2012857. BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 2012857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MARCH-2021. EXPIRATION DATE: 2026-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS SPECIALIST. HIP INTRAPROSTATIC DISLOCATION 3 WEEKS AFTER INDEX IMPLANTATION. A DISLOCATION OCCURED OF THE FEMORAL HEAD FROM THE DOUBLE MOBILITY LINER SUBSEQUENT TO TRAUMATIC EVENT. AT REVISION SURGERY, THE SURGEON DECIDED TO USE A LONGER HEAD TO INCREMENT JOINT TENSION, WHICH MAY MEAN THAT IT WAS NOT SUFFICIENT AT INDEX SURGERY TO MAINTAIN JOINT STABILITY. HOWEVER, DISLOCATION OF THE DOUBLE MOBILITY LINER FROM THE SHELL IS AN UNUSUAL EVENT. ONCE THE LINER DISLOCATED FROM THE SHELL THE LIKELIHOOD OF THE SMALL HEAD COMING OFF THE LINER INCREASES. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. FROM THE RECEIVED PART, IT WAS NOT POSSIBLE TO NOTICE ANY PARTICULAR SIGN ON THE EXPLANTED LINER. A FURTHER QUALITY CONTROL ANALYSIS WAS REQUIRED, REVEALING A SLIGHT OVER-DIMENSIONING OF THE DIAMETER OF RETENTION (OF SLIGHTLY MORE THAN 0.1MM), PROBABLY DUE TO DEFORMATION OF THE INSERT DURING EXPLANTATION. FROM THE RECEIVED PART IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT WITH CERTAINTY, EVEN IF WE CAN DEDUCE THAT IS MOST PROBABLY RELATED TO THE FALL OF THE PATIENT.

    Description of Event or Problem · 0

    AT 3 WEEKS AFTER THE PRIMARY, REVISION SURGERY DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE PATIENT WAS DOING A MOVEMENT BACKWARD WITH THE LEG AND THEN SHE FELL, BUT IT CANNOT SAY IF SHE FELL BECAUSE THE HIP LUXATED OR IF SHE FELL AND THEN THE HIP LUXATED. THE SURGEON REVISED THE LINER AND HEAD (IMPLANTING AN XL INSTEAD OF M). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206880 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG DOUBLE MOBILITY ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2854MHC 2013112 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention