BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 15500917 · Received September 28, 2022

    Report

    Report Number
    3005180920-2022-00727
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05-SEP-2022. LOT 2107500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2021. EXPIRATION DATE: 2026-09-15. 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: BATCH REVIEW PERFORMED ON 05-SEP-2022: STEM: M-VIZION 01.22.408 PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES (K201471) LOT 2007099: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-04-19. 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. STEM: M-VIZION 01.22.106 DISTAL STEM Ø17MM L 140MM STRAIGHT (K170690) LOT 155519B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2021. EXPIRATION DATE: 2026-02-28. 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. BATCH REVIEW PERFOMED ON FATHER LOT 155519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2017. EXPIRATION DATE: 2021-02-09. 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. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2108140: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-07-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.152SH ACETABULAR SHELL Ø52 NO-HOLE (K132879) LOT 2108100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2021. EXPIRATION DATE: 2026-10-07. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED SUCCESSFULLY A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303272 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2107500 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention