BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS:MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

    MDR report key: 8802792 · Received July 18, 2019

    Report

    Report Number
    3005180920-2019-00594
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 JULY 2019: LOT 1810802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 2023-02-28. 2 ANOMALIES FOUND BUT NOT RELATED TO THIS EVENT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E, LOT. (K103721), 1811217. BATCH REVIEW PERFORMED ON 05 JULY 2019: LOT 1811217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-MAR-2019. EXPIRATION DATE: 2024-02-17. 1 ANOMALY FOUND ON THE BATCH BUT NOT RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND ANOTHER SIMILAR EVENT WAS ALREADY REPORTED ON THIS LOT.

    Description of Event or Problem · 1

    18 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT REVISING THE CERAMIC HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598335 BALL HEADS:MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 1810802 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention