BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 23256005 · Received October 9, 2025

    Report

    Report Number
    3005180920-2025-00980
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2025. BALL HEADS: MECTACER 01.29.233H MECTACER HEAD BIOLOX OPTION 12/14 Ø 40 (K131518) LOT 2213136: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 29-AUG-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.052 SMS SOLID STEM STD #12 (K181693) LOT 2204985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2022. EXPIRATION DATE: 27-JUL-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.240A MECTACER SLEEVE 12/14 SIZE S (K131518) LOT 2213136: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 29-AUG-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.158MH ACETABULAR SHELL Ø58 MULTI-HOLE (K132879) LOT 2245007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2023. EXPIRATION DATE: 17-MAY-2028. 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 LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K103721) LOT 2239581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2022. EXPIRATION DATE: 02-NOV-2027. 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 CONCLUSIONS: 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 CAME IN ABOUT 2 YEARS AFTER THE PRIMARY IN DUE TO INFECTION AND THE CAUSE IS UNKNOWN. EVERYTHING WAS REVISED (HEAD, SLEEVE, CUP LINER AND STEM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481207 MECTACER BIOLOX OPTION HEADS MECTACER HEAD BIOLOX OPTION 12/14 Ø 40 LZO MEDACTA INTERNATIONAL SA 01.29.233H 2213136

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention