BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21708477 · Received March 27, 2025

    Report

    Report Number
    3005180920-2025-00241
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 4, 2025
    Report Date
    March 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 MARCH 2025: LOT: 2418029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/07/2024. EXPIRATION DATE: 19/96/2029. 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 IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 11 MARCH 2025: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT: 2421846: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/10/2024. EXPIRATION DATE: 17/09/2029. 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. STEM: AMISTEM P 01.18.403 AMISTEM-P STD STEM SIZE 3 (K173794) LOT: 2409548: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25/06/2024. EXPIRATION DATE: 10/06/2029. 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. CUP: MPACT 01.32.154DH ACETABULAR SHELL Ø54 TWO-HOLES (K132879) LOT: 2400291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25/06/2024. EXPIRATION DATE: 11/06/2029. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416307 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 36 SIZE L LZO MEDACTA INTERNATIONAL SA 01.29.210 2418029 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention