BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 9409888 · Received December 4, 2019

    Report

    Report Number
    3005180920-2019-01030
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2019. LOT 182590: 144 ITEMS MANUFACTURED AND RELEASED ON 24-JUL-18. EXPIRATION DATE: 2023-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 133 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: MINIMAX 01.13.102R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 (K170845) LOT. 181827. BATCH REVIEW PERFORMED ON 22 NOVEMBER 2019. LOT 181827: 15 ITEMS MANUFACTURED AND RELEASED ON 11-JUL-18. EXPIRATION DATE: 2023-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (EVENT REGISTERED ON THE SAME LOT IS CAUSED BY TRAUMA). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER. HIP REVISION SURGERY PERFORMED 8 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A 70 YEAR OLD WOMAN. RADIOGRAPHIC IMAGES PROVIDED SHOW STEM TILTING FROM THE INITIAL POSITION PROBABLY DUE TO UNDER SIZING. THE REASON OF THIS STEM SIZE CHOICE IS UNKNOWN: PATIENT ANATOMY AND BONE MORPHOLOGY MAY HAVE CONTRIBUTED BUT THIS CANNOT BE CONFIRMED ON THE BASIS OF POSTOPERATIVE ANTEROPOSTERIOR IMAGES. WE CANNOT DETERMINE THE CAUSES OF THIS EVENT, BUT WE SEE NO REASON TO THINK THAT THE PROSTHETIC IMPLANTS WERE DEFECTIVE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 9 MONTHS AFTER THE PRIMARY DUE TO LOOSE AND TILTED FEMORAL STEM AND MALPOSITIONED CUP. THE CUP AND THE STEM WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205564 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 182590 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention