BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16813626 · Received April 26, 2023

    Report

    Report Number
    3005180920-2023-00997
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    August 22, 2022
    Report Date
    April 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2101454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-05. 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. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON (B)(6) 2023 ON LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2109535 LOT 2109535: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2021. EXPIRATION DATE: 2026-08-23. 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. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 2101452 LOT 2101452: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-29. 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. BATCH REVIEW PERFORMED ON (B)(6) 2023 ON LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2105745 LOT 2105745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2021. EXPIRATION DATE: 2026-05-04. 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 HAD A RIGHT PRIMARY HIP SURGERY ON (B)(6) 2022 AND A LEFT PRIMARY HIP SURGERY ON 21 MARCH 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY IN BOTH HIPS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER ON BOTH THE RIGHT AND LEFT HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791518 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.205 2101454 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention