BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC Ø 32 / F

    MDR report key: 14494536 · Received May 25, 2022

    Report

    Report Number
    3005180920-2022-00394
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 16, 2022
    Report Date
    July 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807619
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 APRIL 2022: LOT 140099: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28 APRIL 2022: STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE 4 (K093944) LOT 133083: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2013. EXPIRATION DATE: 2018-08-31. 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 MEDACTA MEDICAL AFFAIRS DIRECTOR: 8 YEARS AFTER PRIMARY CEMENTLESS THA, SIGNIFICANT OSTEOLYTIC DAMAGE IS VISIBLE ON XRAYS AROUND THE FEMORAL STEM, WHICH BECAME LOOSE. THE HEAD IS IN A SLIGHTLY ECCENTRIC POSITION, WHICH SUGGESTS THAT POLYETHYLENE WEAR MAY HAVE GENERATED DEBRIS-INDUCED OSTEOLYSIS. THIS MAY BE VERIFIED AT REVISION SURGERY. SIGNIFICANT WEAR OF A HIGHLY CROSSLINKED INSERT AFTER 8 YEARS IS ABNORMAL. ANALYSIS OF THE EXPLANTS IS NECESSARY TO VERIFY IF A THIRD BODY CAN HAVE CAUSED THE ABNORMAL WEAR OR IF THE HEAD WAS DAMAGED. AN UPDATE CAN BE DONE IF THE EXPLANTS ARE RECEIVED AND ANALYZED.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D PROJECT MANAGER: DURING THE VISUAL INSPECTION IT HAS BEEN NOTICED THAT PART OF THE STEM BODY IS COVERED WITH HA COATING MEANING THAT THE STEM WAS NOT CORRECTLY OSSEOINTEGRATED WITH THE PATIENT BONE. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK SURFACE PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 0

    DURING AN XRAYS CONTROL, IT WAS NOTICED THAT OSTEOLYSIS IS PRESENT AROUND THE STEM (GREATER TROCHANTER) AND THE HEAD IS NOT IN THE MIDDLE OF THE POLY LINER. STEM AND LINER WERE REVISED 7 YEARS AND 10 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697697 LINER: CC E CC LIGHT FLAT PE HC Ø 32 / F HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.26.3248HCT 140099 07630030807619

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention