BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD - S Ø28MM

    MDR report key: 16732886 · Received April 13, 2023

    Report

    Report Number
    3008021110-2023-00038
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 12, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS STERILIZED WITH THOSE LOT #S. THEREFORE, THE PRODUCTS WITH THOSE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THOSE LOT #S/STER. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; CLINICAL DATA FOR THE PATIENT. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S - STER.; THE PROSTHESIS HAS BEEN IN PLACE FOR 12 YEARS AND ACCORDING TO THE REPORTED INFORMATION, PATIENT IS IN AN INFECTED STATE, WHICH MIGHT HAVE CONTRIBUTED TO THE REVISION SURGERY; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF FEMORAL MODULAR HEADS - BELONGING TO THE FAMILY CODES 5010.09.XXX - DUE TO INFECTION IS 0.01%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE FOLLOWING COMPONENTS GOT EXPLANTED AND REPLACED WITH SIMILAR COMPONENTS: FEMORAL MODULAR HEAD - S Ø28MM (PRODUCT CODE 5010.09.281, LOT #0600874 - STER. 0600089). MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT #0902420 - STER. 0900211). IT WAS REPORTED THAT A WASHOUT WAS PERFORMED, AND SPECIMENS WERE TAKEN. HOWEVER, THE RESULTS ARE NOT AVAILABLE YET. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2011. ACCORDING TO THE REPORTED INFORMATION, PATIENT IS IN AN INFECTED STATE, AND THIS MIGHT HAVE CONTRIBUTED TO THE NEED TO REVISE. PATIENT IS A MALE, 69 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027348 FEMORAL MODULAR HEAD - S Ø28MM MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM S TAPER 12/14 LPH LIMACORPORATE S.P.A. 5010.09.281 0600874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention