BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 17369519 · Received July 21, 2023

    Report

    Report Number
    3005180920-2023-00552
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2306921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2023. EXPIRATION DATE: 2028-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 6 WEEKS FROM THE PRIMARY CEMENTLESS THA DUE TO AN EARLY INFECTION WITH STAPHYLOCOCCUS AUREUS. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL REVISED IMPLANTS. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON CUP: VERSAFITCUP CC 01.26.45.0058 ACETABULAR SHELL CC TRIO Ø 58 (K103352) LOT. 2240321 LOT 2240321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2023. EXPIRATION DATE: 2027-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON STEM: SMS SOLID 01.36.052 SMS SOLID STEM STD SIZE 12 (K181693) LOT. 2200714 LOT 2200714: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2022. EXPIRATION DATE: 2027-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON LINER: CC E CC LIGHT 01.29.414 CERAMIC LINER Ø 36 / F LOT. 2306164 LOT 2306164: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAR-2023. EXPIRATION DATE: 2028-03-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THIS ITEM IS NOT REGISTERED AND DISTRIBUTED IN US.

    Description of Event or Problem · 0

    AT AROUND 6 WEEKS FROM THE PRIMARY, THE HIP HAD TO BE REVISED DUE TO AN INFECTION WITH STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587127 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2306921 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention