BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR NECK H.90MM

    MDR report key: 15119747 · Received July 28, 2022

    Report

    Report Number
    3008021110-2022-00066
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 12, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT # INVOLVED. NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT WAS FOUND CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS OF THE SAME LOT (LOT. #1517671 AND LOT. #2183634). WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE INVOLVED LOT NUMBER 1517671. NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT WAS FOUND CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS OF THE SAME LOT. ACCORDING TO OUR RECORDS, AT LEAST 8 OUT OF 10 REVISION MODULAR NECK H.90MM WITH LOT #1517671 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. 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; · 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: · THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT NUMBER 1517671; · ACCORDING TO THE INFORMATION PROVIDED, DURING THE PREVIOUS SURGERY CORRECT COMPONENT CHOICE WAS MADE BUT POSSIBLY FACTORS LATER CONTRIBUTED TO THE NEED TO CHANGE BODY SIZE; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF REVISION NECKS - BELONGING TO THE FAMILY CODES 7515.15.0XX AND 7515.15.1XX - DUE TO LEG LENGTH DISCREPANCY IS 0.003%. 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 FINAL MDR.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY AND PAIN. AFTER THE PRIMARY SURGERY PERFORMED ON (B)(6) 2022, PATIENT LEG LENGTH WAS NOTED TO BE LONGER ON THE REVISION HIP SIDE. FOR THIS REASON, DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2022, THE REVISION MODULAR NECK H.90MM (PRODUCT CODE 7515.15.040, LOT. #1517671 - STER. 2100342) AND THE FEM. MODULAR HEAD - M Ø32 MM (PRODUCT CODE 5010.42.322, LOT. #2183634 - STER. 2100344) WERE REMOVED AND A 70 MM STANDARD REVISION BODY AND A NEW FEMORAL HEAD OF 32 MM WERE IMPLANTED . OTHER DETAILS ABOUT THE CLINICAL CONDITION OF THE PATIENT ARE NOT AVAILABLE. THIS EVENT OCCURRED IN AUSTRALIA.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY AND PAIN. AFTER THE PREVIOUS SURGERY PERFORMED ON (B)(6) 2022, PATIENT LEG LENGTH WAS NOTED TO BE LONGER ON THE REVISION HIP SIDE. FOR THIS REASON, DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2022, THE REVISION MODULAR NECK H.90MM (PRODUCT CODE 7515.15.040, LOT. #1517671 - STER. 2100342) AND THE FEM. MODULAR HEAD - M Ø32MM (PRODUCT CODE 5010.42.322, LOT. #2183634 - STER. 2100344) WERE REMOVED AND A 70 MM STANDARD REVISION BODY AND A NEW FEMORAL HEAD OF 32 MM WERE IMPLANTED. IT WAS REPORTED THAT, DURING THE PREVIOUS SURGERY, CORRECT COMPONENT CHOICE WAS MADE BUT POSSIBLY FACTORS LATER CONTRIBUTED TO THE NEED TO CHANGE BODY SIZE. OTHER DETAILS ABOUT THE CLINICAL CONDITION OF THE PATIENT ARE NOT AVAILABLE, NOR ON THE CLINICAL HISTORY OF THE HIP SURGERIES. EVENT OCCURRED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2937091 REVISION MODULAR NECK H.90MM REVISION NECK H. 90 MM LZO LIMACORPORATE S.P.A. 7515.15.040 1517671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention