BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 19392538 · Received May 24, 2024

    Report

    Report Number
    3005180920-2024-00341
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    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 06 MAY 2024 LOT 2113856: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2022. EXPIRATION DATE: 2026-12-13. 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 IMPLANTS INVOLVED BATCH REVIEW PERFORMED ON 06 MAY 2024 ON CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50 (K143453) LOT. 2111691 LOT 2111691: 120 ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2022. EXPIRATION DATE: 2027-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 110 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 06 MAY 2024 ON LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265) LOT. 2118106 LOT 2118106: 110 ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2022. EXPIRATION DATE: 2027-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 HAD HIP INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE MEDACTA HEAD AND LINER WITH A NEW MEDACTA HEAD AND LINER AND REVISED THE MEDACTA CUP WITH A COMPETITOR CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304348 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2113856 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention