BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 8835299 · Received July 29, 2019

    Report

    Report Number
    3005180920-2019-00631
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 JUL 2019: LOT 1806453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 2023-05-03. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP INSTABILITY AND SUBLUXATION 10 MONTHS AFTER PRIMARY IMPLANTATION. THIS EVENT MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY A FAULT IN THE IMPLANTED DEVICES. ADDITIONAL IMPLANT INVOLVED IN THE EVENT: BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 (K080885) LOT. 162373. BATCH REVIEW PERFORMED ON 12 JUL 2019: LOT 162373: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-07-05. 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, 10 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY. THE PATIENT SUBLUXED POSTERIOR WHEN HE BENT OVER. THE SURGEON REVISED THE MEDACTA 36 MM COCR HEAD WITH A MEDACTA 28MM BIOLOX HEAD, AND REVISED THE CUP AND LINER WITH A COMPETITOR'S PRODUCT. A DUAL MOBILITY CUP WITH SCREWS FOR FIXATION WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629523 MPACT FLAT PE HC LINER Ø36/F HIP LINER LPH MEDACTA INTERNATIONAL SA 180653 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention