BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28

    MDR report key: 15885751 · Received November 30, 2022

    Report

    Report Number
    3005180920-2022-00876
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    November 1, 2022
    Report Date
    November 30, 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 03 NOVEMBER 2022. LOT 2105998: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: TWO MONTHS AFTER PARTIAL REVISION OF A RECENT THA, THE PATIENT SUFFERS AN INTRAPROSTHETIC DISLOCATION: THE FEMORAL HEAD DISLOCATES FROM THE RETENTIVE DOUBLE-MOBILITY LINER, ACCORDING TO REPORT. THE FACT IS MOST UNUSUAL, PARTICULARLY BECAUSE THE SAME PROBLEM HAD HAPPENED ONE MONTH AFTER PRIMARY SURGERY. THE EXPLANTED EVICES HAVE NOT BEEN SENT BACK TO MANUFACTURER FOR DIMENSIONAL CHECK. WE HAVE NO KNOWLEDGE OF A FORMER PREVIOUS CASE WITH THIS SEQUENCE OF EVENTS, WITH A 28MM HEAD. NO CLINICAL CAUSE COULD BE IDENTIFIED OR HYPOTHESIZED. ADDITIONAL IMPLANT INVOLVED. BATCH REVIEW PERFORMED ON 03 NOVEMBER 2022 ON LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 2113063 LOT 2113063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607155 BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.230H 2105998 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention