BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/G

    MDR report key: 8188867 · Received December 21, 2018

    Report

    Report Number
    3005180920-2018-01031
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    November 27, 2018
    Report Date
    December 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811999
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 DECEMBER 2018 LOT 134688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JANUARY 2014. EXPIRATION DATE: 2021-10-09. 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 REVISED: STEM: MASTERLOC 01.39.011 CEMENTLESS TI COATED STD STEM # 11 (K151531), LOT 162767:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2016 . EXPIRATION DATE: 2021-06-15. 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. BALL HEADS: COCR 01.25.025 COCR BALL HEAD 12/14 Ø 32 SIZE XXL +10.5 (K072857), LOT 151915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PARTIAL REVISION (STEM AND HEAD) IN PRIMARY CEMENTLESS THA 1,5 YEARS AFTER INDEX OPERATION DUE TO UNSPECIFIED PAIN. WE ONLY HAVE ONE INTRAOPERATIVE FLUOROSCOPY SHOT AND THE ONLY ADDITIONAL ITEM OF INFORMATION IS THAT THE INITIALLY SUSPECTED INFECTION WAS NOT CONFIRMED BY ANALYSIS. WITH THE INFORMATION AT HAND, WE CANNOT DRAW ANY CONCLUSION BUT WE SEE NO EVIDENCE OF A DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT. THE LINER WAS REVISED WITH A MEDACTA LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON OF THE PAIN IS UNKNOWN. IT WAS THOUGHT THAT THE PATIENT MAY BE INFECTED DUE TO SWELLING. THE FROZEN AND MICRO PATHOLOGY REPORTS CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028364 LINER: MPACT FLAT PE HC LINER Ø32/G HIP HC LINER LPH MEDACTA INTERNATIONAL SA 134688 07630030811999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention