BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 9191333 · Received October 15, 2019

    Report

    Report Number
    3005180920-2019-00872
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 15, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2019: LOT 120087: 60 ITEMS MANUFACTURED AND RELEASED ON 28-MARCH-2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 30 SEPTEMBER 2019: CUP: VERSAFITCUP 01.26.52 MB ACETABULAR SHELL CC Ø 52 (K083116) LOT 121034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN -2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 115762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-APR-2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, THREE MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN. THE CAUSE OF THE PAIN WAS AN ALLERGIC REACTION TO NICKEL. THS SURGEON REVISED SUCCESSFULLY HEAD, CUP AND LINER AND IMPLANTED 36 MM BIOLOX DELTA HEAD S, MPACT MULTI HOLE CUP 56 MM AND IMPACT FLAT LINER HC 36/F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984738 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF HIP SHELL LINER MEH MEDACTA INTERNATIONAL SA 120087 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1