BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L

    MDR report key: 16723118 · Received April 12, 2023

    Report

    Report Number
    3005180920-2023-00252
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    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 11-APR-2023: LOT 2237498: (B)(4) MANUFACTURED AND RELEASED ON 24-NOV-2022. EXPIRATION DATE: 2027-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 11-APR-2023: LINER: IMPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2241223: (B)(4) MANUFACTURED AND RELEASED ON 01-DEC-2022. EXPIRATION DATE: 2027-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE POST-OP RECOVERY, THE PATIENT SUSTAINED A JOINT LUXATION. THE SURGEON REVISED SUCCESSFULLY ALL THE HIP SYSTEM THE SAME DAY OF PRIMARY. THE PATIENT WAS NOT TENSIONED ENOUGH DURING PRIMARY SURGERY DUE TO INABILITY TO ACCURATELY GAUGE ROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211266 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 2237498 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other