BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8023980 · Received October 31, 2018

    Report

    Report Number
    3005180920-2018-00854
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2018: LOT 181533: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUNE-2018. EXPIRATION DATE: 2023-05-23. 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. ADDITIONAL COMPONENT INVOLVED IN THE DISLOCATION AND REVISED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115). LOT. 179841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2018. EXPIRATION DATE: 2023-05-28. 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. ON (B)(4) 2018 THE BALL HEAD SUPPLIER (B)(4) REPORTED THE FOLLOWING DOCUMENT REVIEW: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS "FULLFIL" 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 1 MONTH AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT HAD DISLOCATED HER HIP (HEAD DISLOCATED FROM LINER). THE PATIENT SAID THAT SHE DID NOT FALL OR EXPERIENCE ANY TRAUMA. THE SURGEON REVISED THE 32M HEAD TO A 32L. THE LINER WAS NOT REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866522 LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C HIP HC LINER LZO MEDACTA INTERNATIONAL SA 181533 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention