BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR NECK H.60MM

    MDR report key: 18526696 · Received January 17, 2024

    Report

    Report Number
    3008021110-2024-00004
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    January 6, 2024
    Report Date
    April 17, 2024
    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

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2013958, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 30 DEVICES MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2013958, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 30 DEVICES MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 28 OUT OF 30 REVISION NECKS WITH LOT #2013958 AND STER.2000338 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2023 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "FROM THE GIVEN INFORMATION I CANNOT IDENTIFY ANY REASON FOR ONGOING PAIN. THE X-RAY IS INSUFFICIENT AS ONLY A LATERAL VIEW. POSSIBLE REASONS COULD BE CUP MALPOSITION, INFECTION, LUMBAR (DISCOPATHY) ETC.". CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT #2013958; ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT WAS IN CONSISTENT PAIN SINCE THE PREVIOUS SURGERY; ACCORDING TO THE MEDICAL CONSULTANT THE REASON FOR THE PAIN CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, GIVEN THAT "POSSIBLE REASONS COULD BE CUP MALPOSITION, INFECTION, LUMBAR (DISCOPATHY) ETC..."; WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT, STILL WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF REVISION STANDARD MODULAR NECKS - BELONGING TO THE FAMILY CODES 7515.15.0XX - DUE TO PAIN IS 0.01%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES 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 PERFORMED ON (B)(6 2024, DUE TO PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN CONSISTENT PAIN. THE FOLLOWING COMPONENTS GOT EXPLANTED: REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #2013958 - STER. 2000338) FEMORAL MODULAR HEAD - L Ø36MM (PRODUCT CODE 5010.42.363, LOT #1980106 - STER. 1900099) A 60MM LATERALIZED PROXIMAL BODY AND A 36MM MEDIUM CERAMIC FEMORAL HEAD WERE IMPLANTED. THE DISTAL STEM WAS LEFT IN SITU AS IT WAS BELIEVED THAT PAIN WAS NOT CAUSED BY THE FEMORAL STEM. SAMPLES WERE TAKEN TO TEST FOR INFECTION. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2021. IT WAS A REVISION OF A COMPETITOR'S IMPLANT PERFORMED FOR UNKNOWN REASON. DURING IT, LIMA'S DEVICES WERE IMPLANTED. IT WAS REPORTED THAT PAIN WAS PRESENT AFTER THE FIRST REVISION. PATIENT IS A FEMALE, 73 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN CONSISTENT PAIN. THE FOLLOWING COMPONENTS GOT EXPLANTED: REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #2013958 - STER. 2000338). FEMORAL MODULAR HEAD - L Ø36MM (PRODUCT CODE 5010.42.363, LOT #1980106 - STER. 1900099). A 60MM LATERALIZED PROXIMAL BODY AND A 36MM MEDIUM CERAMIC FEMORAL HEAD WERE IMPLANTED. THE DISTAL STEM WAS LEFT IN SITU AS IT WAS BELIEVED THAT PAIN WAS NOT CAUSED BY THE FEMORAL STEM. SAMPLES WERE TAKEN TO TEST FOR INFECTION, BUT RESULTS WEREN'T ACCESSIBLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. IT WAS A REVISION OF A COMPETITOR'S IMPLANT PERFORMED FOR UNKNOWN REASON. DURING IT, LIMA'S DEVICES WERE IMPLANTED. IT WAS REPORTED THAT PAIN WAS PRESENT AFTER THAT FIRST REVISION. PATIENT IS A FEMALE, 73 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717465 REVISION MODULAR NECK H.60MM REVISION NECK H. 60 MM LZO LIMACORPORATE S.P.A. 7515.15.010 2013958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention