BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32 / E

    MDR report key: 8235402 · Received January 10, 2019

    Report

    Report Number
    3005180920-2018-01088
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 14, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807572
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 JANUARY 2019. LOT 181144: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2018. EXPIRATION DATE: 2023-05-08 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. OTHER DEVICES INVOLVED: REFERENCE 01.25.025 (K072857) COCR BALL HEAD 12/14 Ø 32 SIZE XXL +10.5; LOT 163216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2016 . EXPIRATION DATE: 2021-07-18. 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. CERAMIC BALL HEAD NOT MARKETED IN US. MANUFACTURER HAS BEEN INFORMED ABOUT THE ISSUE. ON DECEMBER 21, 2018 THEY REPORTED THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON JANUARY 07, 2019. PARTIAL HIP REVISION SURGERY (STEM, HEAD AND LINER) OCCURRED FEW MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. RECURRENT DISLOCATIONS OCCURRED PROBABLY DURING REHABILITATION PERIOD. HIP DISLOCATION MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY STANDARD DEVICES.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TWO TIMES ((B)(6) 2018) DUE TO HIP DISLOCATION, 4 AND 5 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27204 LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32 / E LINER LZO MEDACTA INTERNATIONAL SA 181144 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention