BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DM CONVERTER TIN COATED D/DMB

    MDR report key: 19623329 · Received June 27, 2024

    Report

    Report Number
    3005180920-2024-00440
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971256347
    PMA / PMN Number
    K211891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JUNE 2024 LOT 2302176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2023. EXPIRATION DATE: 2028-06-24. 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. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: LINER: MPACT DM 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB (K131458) LOT 2314368: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2023. EXPIRATION DATE: 2028-09-12. 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 HAD A PRIMARY WITH MPACT NO HOLE CUP, MPACT DM CONVERTER AND DOUBLE MOBILITY LINER IMPLANTED ON THE (B)(6) 2024. THE CUP WAS PLACED AS USUAL, 40 INCLINATION AND ROUGHLY 20 ANTEVERSION. THE PATIENT SHOWED SIGNS OF A SPINAL DEFORMITY. THE PATIENT DISLOCATED POSTERIORLY 3 TIMES OVER IN 2 WEEKS. IT WAS FOUND THAT THE PATIENT HAD AN EXTREMELY HYPER MOBILE HIP (EXTREMELY LAX IN HER LIGAMENTS) AND HER HIP POSTERIOR CAPSULE WAS DETACHED. THE SURGEON DECIDED TO REMOVE THE MPACT NO HOLE CUP WITH DM CONVERTER LINER, THE DOUBLE MOBILITY LINER AND PUT IN A HIGHLY CONSTRAINED CUP (OF COMPETITOR). THIS WAS DONE ON THE (B)(6) 2024. THE SURGEON REPORTED THAT HE DOES NOT BELIEVE THIS WAS AN IMPLANT FAULT, THE PATIENT JUST REQUIRED A MORE CONSTRAINT HIP CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434907 LINER: MPACT DM DM CONVERTER TIN COATED D/DMB HIP DM CONVERTER TIN COATED LZO MEDACTA INTERNATIONAL SA 2302176 07630971256347

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention