BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 17918115 · Received October 12, 2023

    Report

    Report Number
    3005180920-2023-00800
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 26 SEPT 2023: LOT 2207389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2022. EXPIRATION DATE: 2027-JUN-14. 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. OTHER IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 26 SEPT 2023: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2209947: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2022. EXPIRATION DATE: 2027-JUN-07. 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. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT 2111217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-SEP-06. 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. SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L30 (K103721) LOT 2208635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-JUN-01. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, HEAD, AND SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143308 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2207389 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention