BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F

    MDR report key: 8319901 · Received February 8, 2019

    Report

    Report Number
    3005180920-2019-00035
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 FEBRUARY 2019: LOT 182616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2018. EXPIRATION DATE: 2023-06-25. 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 COMPONENT INVOLVED: BATCH REVIEW PERFORMED ON 07 FEBRUARY 2019: LOT 181638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2018. EXPIRATION DATE: 2023-07-03. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE LINER WAS RECEIVED FRAGMENTED WITH SEVERAL CUTS IN AN AREA. THE MPACT SHELL HAD SEVERAL SCRATCHES ON THE INTERNAL SURFACE, ESPECIALLY ON THE CONICAL AREA, PROBABLY OCCURRED DURING THE REMOVAL OF THE CUP. IT WAS NOTICED THAT THE DAMAGED PART IS ON A SPECIFIC AREA OF THE LINER; IT IS POSSIBLE THAT THE EVENT IS DUE TO AN IMPACTION OF THE LINER NOT COAXIAL WITH THE CUP, WHICH CAUSED THE IMPOSSIBILITY OF CONNECTION WITH THE CUP AND THE BREAKAGE OF THE LINER.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A SIZE 58 MPACT CUP, THEN WANTED TO IMPLANT A 36 F FLAT MPACT LINER. HE FELT IT WAS WRONG SIZE, SO THE AGENT CHECKED THE ENSURE SIZE WAS CORRECT BEFORE FURTHER IMPACTION. SIZE WAS CORRECT. HE CONTINUED TO IMPACT WITH FORCE AND COULDN'T GET LINER TO SEAT FLAT. AS A RESULT WE HAD TO REMOVE THE LINER WHICH DAMAGED THE CUP AND LINER. A NEW CUP (SIZE 60) WAS IMPLANTED ALONG WITH A 36 G FLAT MPACT LINER TO MATCH. CUP AND LINER ARE BEING SENT BACK TO CSP FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112218 LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F HIP HC LINER LPH MEDACTA INTERNATIONAL SA 182616 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other