BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S -4

    MDR report key: 11999155 · Received June 15, 2021

    Report

    Report Number
    3005180920-2021-00497
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    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 31 MAY 2021: LOT 180530: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUNE-2018. EXPIRATION DATE: 2023-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 31 MAY 2021: STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0 (K093944) LOT 177141: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2018. EXPIRATION DATE: 2023-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 180650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2018. EXPIRATION DATE: 2023-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN 2 YEARS 6 MONTHS AFTER THE PRIMARY AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901896 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S -4 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 180530 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention