BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

    MDR report key: 16831290 · Received April 28, 2023

    Report

    Report Number
    3005180920-2023-00299
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    April 1, 2023
    Report Date
    April 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    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 19-APR-2023. LOT 2211895: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2022. EXPIRATION DATE: 2027-07-27. 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. OTHER DEVICES INVOLVED: LINER: MPACT 01.32.3241HC10A FACE-CHANGING 10° PE HC LINER Ø32/D (K183582) LOT 1810848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2019. EXPIRATION DATE: 2024-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 3 OTHER SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2022 WITH COMPETITOR COMPONENTS AND CAME IN FOR REASONS UNKNOWN. THE SURGEON IMPLANTED SUCCESSFULLY A MEDACTA CUP AND LINER AND RETAINED THE COMPETITOR'S HEAD AND STEM. ON (B)(6) 2023, THE PATIENT CAME IN FOR REASONS UNKNOWN AND THE SURGEON REVISED SUCCESSFULLY THE COMPETITOR STEM AND HEAD WITH A MEDACTA STEM AND HEAD. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477130 BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 2211895 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention