BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER 32 / C

    MDR report key: 10069359 · Received May 19, 2020

    Report

    Report Number
    3005180920-2020-00286
    Event Type
    Injury
    Date Received
    May 19, 2020
    Date of Event
    May 15, 2019
    Report Date
    May 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT THE REPORT DATE WAS WRONG. IT WAS CORRECTED WITH MAY 19TH 2020.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 APRIL 2020: LOT 182621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2018. EXPIRATION DATE: 2023-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28 APRIL 2020 BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 186540. LOT 186540: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2018. EXPIRATION DATE: 2023-11-19. 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 HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT CAME IN REPORTING PAIN, WHICH WAS CAUSED BY A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE 32MM BIOLOX S HEAD WITH A 32MM BIOLOX M HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, 11 MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532704 LINER: CC E CC LIGHT FLAT PE HC LINER 32 / C FLAT PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.26.3239HCT 182621 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention