BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT PE LINER

    MDR report key: 5673124 · Received May 23, 2016

    Report

    Report Number
    3005180920-2016-00239
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 26, 2016
    Report Date
    August 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 20 MAY 2016. MPACT FLAT PE HC LINER Ø36/E, CODE (B)(4): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2016. EXPIRATION DATE: 2021-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND ANOTHER SIMILAR EVENT HAS BEEN ALREADY REPORTED ON AN ITEM OF THE SAME LOT ((B)(4)). MPACT ACETABULAR SHELL Ø54 TWO-HOLES CODE (B)(4) LOT. 155991 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 FEBRUARY 2016. EXPIRATION DATE: 2021-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND THE FOLLOWING CONCLUSION: NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED AS THE DEVICE WAS NOT AVAILABLE FOR REVIEW, HOWEVER IT IS POSSIBLE THAT THE IMPACTION WAS DONE IN SUCH A WAY THAT NON-PERPENDICULAR FORCES WERE APPLIED WHICH COULD HAVE THEN CAUSED INTERFERENCE BETWEEN THE DEVICES AND POSSIBLY DAMAGE PREVENTING FURTHER ATTEMPTS. IMPACTION SHOULD FOLLOW THE AXIS OF THE CUP (I.E. IN A DIRECTION PERPENDICULAR TO THE PLANE OF THE EQUATOR OF THE CUP). IN ORDER TO DO SO, THE OFFSET AMIS IMPACTOR IS AVAILABLE TO HELP FACILITATE NEGOTIATING SOFT TISSUES. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED CAUSE. THE DESIGN CONFIGURATION CURRENTLY APPLIED IS NECESSARY TO ACHIEVE ADEQUATE LONG-TERM PERFORMANCE AND THE MANUFACTURING PROCESSES WERE CONDUCTED ACCORDING TO THE ESTABLISHED SPECIFICATIONS. NO SYSTEMIC DEVICE DEFICIENCY IS IDENTIFIED. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY THE LINER WOULD NOT SEAT PROPERLY. THE SURGEON MADE SEVERAL ATTEMPTS TO SEAT THE LINER. THE SURGERY WAS DELAYED BY 4-5 MINUTES. THE SURGEON USED ANOTHER LINER TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326488 MPACT PE LINER ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 157512

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other