BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

    MDR report key: 8581491 · Received May 6, 2019

    Report

    Report Number
    3005180920-2019-00347
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 6, 2019
    Report Date
    May 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    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 03 MAY 2019: LOT 187080: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-11-26. 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 IMPLANTS INVOLVED: STEM: MINIMAX 01.13.102R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 (K170845), LOT 185945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-11-25. 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. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721), LOT 187907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2023-07-11. 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, 2 WEEKS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374611 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 187080 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention