BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER 28 / E

    MDR report key: 12267572 · Received August 3, 2021

    Report

    Report Number
    3005180920-2021-00651
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 20, 2021
    Report Date
    October 11, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807176
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER ON 14 SEPTEMBER 2021: HIP DISLOCATION 1 YEAR AND 5 MONTHS AFTER PRIMARY IMPLANTATION. HIP DISLOCATION MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY STANDARD DEVICES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20.07.2021. LOT 181142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 20.07.2021. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 1901932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO DISLOCATION. LINER AND HEAD HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162566 LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER 28 / E HIP LINER FLAT LZO MEDACTA INTERNATIONAL SA 01.26.2844HCT 181142 07630030807176

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention