BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER HEAD BIOLOX OPTION Ø 28

    MDR report key: 15624382 · Received October 18, 2022

    Report

    Report Number
    3005180920-2022-00795
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809323
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-OCT-2022: LOT 22C0009: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2022. EXPIRATION DATE: 2027-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 18-OCT-2022: BALL HEADS: MECTACER 01.29.242A SLEEVE SIZE L (K131518) LOT 2114384: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2022. EXPIRATION DATE: 2027-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 (K092265) LOT 2202287: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2022. EXPIRATION DATE: 2027-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351747 MECTACER HEAD BIOLOX OPTION Ø 28 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.230H 22C0009 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention