BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 19749803 · Received July 16, 2024

    Report

    Report Number
    3005180920-2024-00515
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JUNE 2024: LOT 134682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2013. EXPIRATION DATE: 2018-OCT-31. 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 DEVICES INVOLVED BATCH REVIEW PERFORMED ON 15 JULY 2024 BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 (K072857) LOT 151912: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2015. EXPIRATION DATE: 2020-JUN-30. 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. STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3 (K093944) LOT 153422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-SEP-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 CAME IN REPORTING PAIN DUE TO INSTABILITY AND LAXITY IN THE HIP AND THE CAUSE IS UNKNOWN. ABOUT 8 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (WITH FLAT PE HC LINER Ø36/E) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738881 MPACT FLAT PE HC LINER Ø32/E HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 134682 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention