BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER #L FOR MOBILE LINER Ø42

    MDR report key: 17648148 · Received August 30, 2023

    Report

    Report Number
    3008021110-2023-00105
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 24, 2023
    Report Date
    August 29, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K181491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2203120, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, LINERS WITH LOT #2203120 - STER. 2200106 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY, NO DETAILS ON PATIENT'S HISTORY NOR ADDITIONAL INFORMATION ON THE REVISION SURGERY. THEREFORE, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. BASED ON THE INFORMATION RECEIVED AND CONSIDERING THAT THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE DEVICES MANUFACTURED WITH THE INVOLVED LOT #2203120, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF LINERS FOR MOBILE LINERS BELONGING TO PRODUCT CODES 5885.09.040 AND 5885.09.042 DUE TO BONE FRACTURE 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 KEEPS MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6) 2023, DUE TO BONE FRACTURE. THE METAL HEAD AND THE ADAPTER WERE FROM ANOTHER MANUFACTURER AND GOT EXPLANTED TOGETHER WITH THE LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE 5885.09.042, LOT #2203120 - STER. 2200106). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. IT WAS REPORTED IT WAS NOT A PRIMARY SURGERY, HOWEVER PATIENT'S HISTORY IS UNKNOWN. PATIENT IS A MALE, 81 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302422 LINER #L FOR MOBILE LINER Ø42 DELTA DUAL MOBILITY SYSTEM LZO LIMACORPORATE S.P.A. 5885.09.042 2203120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention