BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 21033632 · Received December 30, 2024

    Report

    Report Number
    3005180920-2024-01131
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 10, 2024
    Report Date
    February 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809323
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6), WE RECEIVED INFORMATION THAT THIS WAS A STANDARD DISLOCATION AND NOT AN INTERPROSTETIC ONE. DEVICES INVOLVED IN THE COMPLAINT BATCH REVIEW PERFORMED ON (B)(6)2025 LINER: MPACT DM 01.32.4452CF DM CONVERTER TIN COATED G/DMF (K211891) LOT 2310983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-11-2023. EXPIRATION DATE: 2028-10-24. 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. B5 AND H6 UPDATED. THE COMPLAINT ROOT CAUSE REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12-DEC-2024: LOT 2417354: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-07-2024. EXPIRATION DATE: 2029-06-13. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 12-DEC-2024: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT. 2409372 LOT 2409372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-05-2024. EXPIRATION DATE: 2029-05-06. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    CORRECTED DESCRIPTION: ONE WEEK AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LUXATION OF THE DOUBLE MOBILITY LINER FROM THE DM CONVERTER (METALLIC LINER). THE SURGEON REVISED HEAD, LINER AND DM CONVERTER. BIOLOX OPTION WAS USED DURING PRIMARY TO ACHIEVE AN XL LENGTH WHILE STILL RETAINING THE WEAR CHARACTERISTICS OF A CERAMIC HEAD FOR A SIZE 28MM DIAMETER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT CAME BACK ON THE (B)(6) WITH SIGNS OF AN INFECTION, (B)(4) WAS FILED.

    Description of Event or Problem · 0

    ONE WEEK AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISSOCIATION OF THE HEAD FROM THE DOUBLE MOBILITY LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731510 MECTACER BIOLOX OPTION HEADS HEAD BIOLOX OPTION Ø 28 LOT. 2417354 LZO MEDACTA INTERNATIONAL SA 01.29.230H 2417354 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention