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: 17078594 · Received June 7, 2023

    Report

    Report Number
    3005180920-2023-00424
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    May 15, 2023
    Report Date
    June 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 MAY 2023. LOT 2237488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2023. EXPIRATION DATE: 2028-JAN-15. 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. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON 22 MAY 2023 ON CUP: MPACT 01.32.154DH ACETABULAR SHELL Ø54 TWO-HOLES (K132879) LOT. 2243243. LOT 2243243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2023. EXPIRATION DATE: 2028-FEB-09. 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 22 MAY 2023 ON LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 2247622. LOT 2247622: 100 ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2023. EXPIRATION DATE: 2028-FEB-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 80 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 22 MAY 2023 ON STEM: SMS SOLID 01.36.044 SMS SOLID STEM STD SIZE 4 (K181693) LOT. 2117866. LOT 2117866: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-APR-13. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481973 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.208 2237488 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention