BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10860236 · Received November 18, 2020

    Report

    Report Number
    3005180920-2020-00807
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2020: LOT 185168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-10-22. 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 DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 30 OCTOBER 2020: STEM: AMISTEM-H PROX. COAT. 01.18.172 AMISTEM-H PROXIMAL COATING STD STEM SIZE 2 (K161635) LOT 184653: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2018. EXPIRATION DATE: 2023-09-30. 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: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352) LOT 187113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-12-31. 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. CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 (K103352) LOT 188847: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2019. EXPIRATION DATE: 2024-01-02. 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

    REVISION SURGERY PERFORMED 1 YEAR AND 6 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN. DURING SURGERY SOME LIQUID CAME OUT FROM THE JOINT, THERE WAS A SPACE BETWEEN THE CORTICAL BONE AND THE STEM IN THE VENTRAL PROXIMAL ZONE, BUT IMPOSSIBLE TO TAKE THE STEM OUT. FINALLY THE SURGEON LEFT THE STEM IN AND REPLACED THE HEAD WITH A HEAD BIOLOX OPTION 32M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327097 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 185168 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention