BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/ER

    MDR report key: 11027986 · Received December 17, 2020

    Report

    Report Number
    3005180920-2020-00905
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 NOVEMBER 2020: LOT 1907434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-OCT-2019. EXPIRATION DATE: 2024-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION REVISION SURGERY PERFORMED FEW WEEKS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. THE REASON FOR REVISION IS AN EARLY INFECTION, A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED ON 16TH DECEMBER 2020. THE LINER HAD SOME SIGNS AND SKETCHES; FROM THE ANALYZED PIECES, THEIR SIGNS ARE PROBABLY DUE TO THE PRESENCE OF A THIRD BODY, EVEN IF THERE WAS NOT ANY REMIND OF PRESECE OF IT. ANYWAY, FROM THE RECEIVED PARTS AND INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. OTHER DEVICES INVOLVED IN THE EVENT: STEM: QUADRA-C 01.12.055 CEMENTED, MIRROR POLISHING LAT STEM SIZE 5 12/14 LOT. 1900129 (K083558) BATCH REVIEW PERFORMED ON 27 NOVEMBER 2020: LOT 1900129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-06. 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 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 LOT. 1910898 (K112115): BATCH REVIEW PERFORMED ON 27 NOVEMBER 2020: LOT 1907434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2020. EXPIRATION DATE: 2025-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 1 MONTH AFTER PRIMARY FOR HIP INFECTION. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492156 LINER: MPACT FLAT PE HC LINER 36/ER FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention