BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR STEM Ø14MM

    MDR report key: 16013592 · Received December 20, 2022

    Report

    Report Number
    3008021110-2022-00131
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    December 12, 2022
    Report Date
    December 19, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    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 ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, ALL THE PRODUCTS 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 PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, HOWEVER THEY WERE NOT AVAILABLE. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S - STER.; ACCORDING TO THE RECEIVED INFORMATION, PATIENT HAS DENTAL INFECTION THAT HAS MIGRATED TO THE HIP COMPONENTS; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF REVISION STEMS - BELONGING TO THE FAMILY CODES 38XX.15.0X0 - DUE TO INFECTION IS (B)(4). 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 INFECTION. ACCORDING TO THE RECEIVED INFORMATION, PATIENT HAS DENTAL INFECTION THAT HAS MIGRATED TO THE HIP COMPONENTS. THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS CURRENTLY NOT KNOWN, HOWEVER SPECIMEN WAS TAKEN. IT WAS REPORTED THAT THE IMPLANTED DEVICES WERE EXTREMELY WELL FIXED DESPITE THE INFECTION AND THE PROSTHESIS WAS FUNCTIONING WELL UNTIL THE DENTAL INFECTION MIGRATED. ALL IMPLANTS WERE REMOVED: REVISION MODULAR STEM Ø14MM (PRODUCT CODE 3810.15.020, LOT #2024956 - STER. 2100012). REVISION MODULAR NECK H.80MM (PRODUCT CODE 7515.15.030, LOT #2008119 - STER. 2000235). FEMORAL MODULAR HEAD - L Ø36MM (PRODUCT CODE 5010.42.363, LOT #2082313 - STER. 2000309). DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1714791 - STER. 1800011). DELTA-ONE-TT ACETABULAR CUP Ø60MM (PRODUCT CODE 5549.14.600, LOT #1908172 - STER. 2000258) - PRODUCT NOT SOLD IN THE US BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2105835 - STER. 2100141). NEW CEMENTED COMPONENTS WERE PLACED IN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, 39 YEARS OLD. SHE HAS RHEUMATOID ARTHRITIS. THE DETAILED HISTORY OF HIP SURGERIES IS NOT KNOWN; HOWEVER, IT WAS REPORTED THAT SHE HAD AN INITIAL INFECTION, DUE TO WHICH ALL PRIMARY HIP COMPONENTS WERE REMOVED AND REPLACED WITH THE ABOVE LISTED DEVICES. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701552 REVISION MODULAR STEM Ø14MM REVISION STEM DIA. 14 MM, L. 200 MM LZO LIMACORPORATE S.P.A. 3810.15.020 2024956

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention