BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY SHELLS

    MDR report key: 18747785 · Received February 21, 2024

    Report

    Report Number
    3005180920-2024-00049
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 22, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JANUARY 2024: LOT 2216884: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2022. EXPIRATION DATE: 2027-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER. FROM THE RECEIVED PIECES, NO EVIDENT SIGNS OF DEFECTS WERE PRESENT ON THE DEVICES. THE EVENT COULD BE PROBABLY RELATED TO AN EXCESSIVE LAXITY OF THE PATIENT MUSCLES/TISSUES OR TO THE POSITIONING OF THE ACETABULAR SHELL, BUT WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. OTHER DEVICE INVOLVED: LINER: MPACT DM 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB (K131458) LOT 2245568: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-05. 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 Manufacturer Narrative · 0

    DURING A RANDOM MDR CHECK CONDUCTED ON OCTOBER 1, 2024, SOME ERRORS WERE NOTICED. A FOLLOW-UP IS BEING INITIATED TO CORRECT THEM. CORRECTION: THE K NUMBER WAS IN THE DEVICE BLA FIELD INSTEAD OF IN THE PMA/510(K). BRAND NAME HAS BEEN CORRECTED IN D1 SECTION. REFERENCE INSERTED IN MODEL FIELD OF D4 SECTION. H3. DEVICE EVALUATED BY MANUFACTURER NO: IT HAS BEEN CORRECTED WITH "YES".

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 MARCH 2024: LOT 2216884: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2022. EXPIRATION DATE: 2027-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER FROM THE RECEIVED PIECES, NO EVIDENT SIGNS OF DEFECTS WERE PRESENT ON THE DEVICES. THE EVENT COULD BE PROBABLY RELATED TO AN EXCESSIVE LAXITY OF THE PATIENT MUSCLES/TISSUES OR TO THE POSITIONING OF THE ACETABULAR SHELL, BUT WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. UPDATE AT 11 MARCH 2024: ALSO FOR THE ACETABULAR SHELL, THERE ARE NO EVIDENT SIGNS OF DEVICE DEFECTS RELATED TO THE STABILITY WITH THE ACETABULUM, BOTH IN THE CUP AND IN THE COATING. FROM THE RECEIVED INFORMATION, WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT. INFORMATION AND CORRECTIONS REPORTED IN THIS MDR: BATCH OF THE CUP HAS BEEN PERFORMED AGAIN BASED ON THE NEW INFORMATION RECEIVED (SHELL CAME OUT FROM THE INTENDED POSITION). MIGRATION INSERTED IN "MEDICAL DEVICE CODE."

    Description of Event or Problem · 0

    DURING THE FINAL IMPLANTS CHECK THE LINER DISLOCATED FROM THE CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NEW CUP AND LINER. DELAY TIME DUE TO THIS EVENT WAS 1HR AND TOTAL SURGERY TIME WAS 3.5HR. THE DELAY WAS DUE TO NEW ACETABULAR REAMING, BONE GRAFT (NEEDED FOR THE DESIGN OF THE COMPETITOR CUP FINALLY IMPLANTED), COMPETITOR CUP TRIAL, CUP INSERT IMPLANTATION, STEM AND HEAD INSERTION, FINAL CHECK OF THE HIP STABILITY.

    Description of Event or Problem · 0

    DURING THE FINAL IMPLANTS STABILTY CHECK THE SHELL CAME OUT OF THE ACETABULAR BONE. THE INSERT DISLOCATED FROM THE SHELL. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NEW CUP AND LINER. DELAY TIME DUE TO THIS EVENT WAS 1HR AND TOTAL SURGERY TIME WAS 3.5HR.THE DELAY WAS DUE TO NEW ACETABULAR REAMING, BONE GRAFT (NEEDED FOR THE DESIGN OF THE COMPETITOR CUP FINALLY IMPLANTED), COMEPTITOR CUP TRIAL, CUP INSERT IMPLANTATION, STEM AND HEAD INSERTION, FINAL CHECK OF THE HIP STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89418 MPACT DOUBLE MOBILITY SHELLS HIP DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.144MB 2216884

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other