BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE LINER INT 28 MM 40 MM

    MDR report key: 9909309 · Received April 1, 2020

    Report

    Report Number
    3008021110-2020-00017
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 26, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K181491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ORDER TO ASSESS THAT ALL THE INVOLVED COMPONENTS WERE UP TO MANUFACTURING AND STERILIZATION SPECIFICATIONS, WE CHECKED THE DHRS OF THE ALL INVOLVED LOTS. WE DID NOT FIND ANY PRE-EXISTING ANOMALY ON: (B)(4) MOBILE LINERS MANUFACTURED WITH LOT# 19AT0HF, STER.1900189. (B)(4) LINERS MANUFACTURED WITH LOT# 1904712, STER.1900181. (B)(4) DELTA NATURAL SPACERS MANUFACTURED WITH LOT# 1520674, STER.1600040. THEREFORE, WE CAN ASSUME THAT ALL THE INVOLVED COMPONENTS WERE STERILIZED ACCORDING TO SPECIFICATIONS BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT DUE TO INFECTON ON THESE LOT #S. XRAYS IMAGES AND SWAB ANALYSIS WERE NOT AVAILABLE FOR INVESTIGATION. COMPLAINT SOURCE REPORTED THAT THE PATIENT OBTAINED HIP STABILITY AFTER PREVIOUS SURGERY WITH LIMA ACETABULAR COMPONENTS AND HAD BEEN DOING VERY WELL APART FROM WHAT HE CALLED A LOW GRADE INFECTION. CONSIDERING THAT THE CHECK OF THE MANUFACTURING CHART FOUND ALL THE COMPONENTS UP TO SPECIFICATIONS AND THAT (B)(4) MOBILE LINERS, (B)(4) LINERS AND (B)(4) DELTA NEUTRAL SPACERS HAVE BEEN ALREADY IMPLANTED WITHOUT RECEIVING ANY ADDITIONAL COMPLAINT, WE CANNOT JUDGED THIS CASE AS PRODUCT RELATED. PMS DATA ON THE BASIS OF OUR PMS DATA, OCCURRENCE RATE OF INFECTION ON DUAL MOBILITY SYSTEM IS (B)(4). NONE OF THESE CASE WAS JUDGED AS PRODUCT RELATED. LIMACORPORATE WILL KEEP THE MARKET MONITORED. NO CORRECTIVE ACTION WAS PERFORMED FOR THIS SPECIFIC CASE. PLEASE, CONSIDER THIS REPORT AS INITIAL-FINAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. DURING REVISION, WASHOUT OF THE INNER SURFACE OF DELTA TT CUP WAS PERFORMED AND ONLY THE FOLLOWING COMPONENTS WERE REPLACED: MOBILE LINER ØINT 28 MM Ø40 MM, CODE 5566.50.401, LOT# 19AT0HF, STER.1900189. LINER #M FOR MOB. LINER Ø40, CODE 5885.09.040, LOT# 1904712, STER.1900181. DELTA NEUTRAL SPACER SIZE L+5, NOT MARKED IN USA. THE STEM WAS LEFT IN SITU. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375908 MOBILE LINER INT 28 MM 40 MM MOBILE LINER (LZO, LPH, MBL) LZO LIMACORPORATE SPA 5566.50.401 19AT0HF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention