BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD - L Ø28MM

    MDR report key: 13803608 · Received March 18, 2022

    Report

    Report Number
    3008021110-2022-00016
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 16, 2022
    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

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND. ALL PRODUCTS PLACED ON THE MARKET WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. 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: X-RAYS RELATED TO THE REVISION SURGERY; PATIENT'S CLINICAL DATA. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S; ACCORDING TO THE COMPLAINT SOURCE, PATIENT WAS IN AN INFECTED STATE WHICH CONTRIBUTED TO THE NEED TO PERFORM THE REVISION; 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 PRODUCT 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) 2022, DUE TO PROSTHETIC JOINT INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH SAME SIZE COMPONENTS: FEMORAL MODULAR HEAD - L Ø28MM (PRODUCT CODE 5010.09.283, LOT #1807870 - STER. 1800237) . MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #18AT1T5 - STER. 1800302). IT WAS REPORTED THAT CUP AND STEM WERE WELL FIXED. ACCORDING TO THE COMPLAINT SOURCE, SPECIMEN SAMPLE WAS TAKEN, HOWEVER IT IS NOT KNOWN WHICH PATHOGEN IS RESPONSIBLE FOR THE INFECTION. PATIENT'S CLINICAL HISTORY OF HIP SURGERIES IS THE FOLLOWING: PRIMARY SURGERY TOOK PLACE ON (B)(6) 2017; FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2018, AND IT WAS DUE TO INFECTION. THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2018-00120; SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION (HEREBY REPORTED). IT WAS REPORTED THAT THE PATIENT WAS IN AN INFECTED STATE WHICH CONTRIBUTED TO THE NEED TO PERFORM THE REVISION. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515231 FEMORAL MODULAR HEAD - L Ø28MM MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM L TAPER 12/14 LPH LIMACORPORATE S.P.A. 5010.09.283 1807870

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention