BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2

    MDR report key: 8789471 · Received July 15, 2019

    Report

    Report Number
    3005180920-2019-00613
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 15, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803185
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 JULY 2019: LOT 169043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2017. EXPIRATION DATE: 2022-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY (STEM, HEAD AND LINER) PERFORMED 7 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. ACCORDING TO THE REPORT, THE REASON FOR REVISION IS LEG LENGTH DIFFERENCE DUE TO SEVERE SCOLIOSIS THAT CANNOT BE CONFIRMED ON THE BASIS OF THE PARTIAL X-RAY IMAGE PROVIDED. EXPLANT PICTURES SHOW THE PRESENCE OF BONE ON THE STEM SURFACE SUGGESTING GOOD OSSEOINTEGRATION AND FIXATION OF THE STEM. ON THE BASIS OF INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: PRELIMINARY VISUAL INVESTIGATION SHOWS STEM COVERED IN BIO FLUIDS AND MASSIVE BONE STOCK ADHESION ON THE LATERAL SIDE. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 04 JULY 2019. BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT. 183349. LOT 183349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEP-2018. EXPIRATION DATE: 2023-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: MECTACER 01.29.409 CERAMIC LINER Ø 32 / D LOT. 165467 (DEVICE NOT DISTRIBUTED IN THE USA). LOT 165467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2016. EXPIRATION DATE: 2021-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2019 WE WERE ALERTED OF A REVISION PERFORMED ON (B)(6) 2019. REVISION SURGERY HAS BEEN PERFORMED 6 MONTHS AFTER PRIMARY DUE TO LEG LENGTH DISCREPANCY, 15 MM (APPARENTLY DUE TO SEVERE SCOLIOSIS OF THE SPINE). THROUGH A POSTERIOR APPROACH THE SURGEON REMOVED THE STEM, LINER AND HEAD. HE REPLACED THESE EXPLANTED ITEMS WITH AN MPACT HOODED LINER AND A COMPETITOR REVISION STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581745 MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 169043 07630030803185

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention