BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER #M FOR MOBILE LINER Ø40

    MDR report key: 15970224 · Received December 13, 2022

    Report

    Report Number
    3008021110-2022-00129
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    December 6, 2022
    Report Date
    March 22, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K181491
    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 LOTS #1310635, #1400499 AND #1304835, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1400499, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #S. ACCORDING TO OUR RECORDS, AT LEAST 7 OUT OF 10 LINERS WITH LOT #1400499 - STER. (B)(6) HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS: 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 PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, BUT THEY WERE NOT AVAILABLE. 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 MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #1400499, AND NO OTHER COMPLAINT WAS RECEIVED ON THAT LOT #, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF LINERS FOR DUAL MOBILITY - BELONGING TO THE FAMILY CODES 5885.09.040 AND 5885.09.042 - DUE TO DISLOCATION IS 0.04%. 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 PERFORMED ON (B)(6) 2022 DUE TO IMPLANT DISLOCATION. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #1310635 - STER. 1300275) LINER #M FOR MOBILE LINER Ø40 (PRODUCT CODE 5885.09.040, LOT #1400499 - STER. 1400041) DELTA ANGLED SPACER 20°# L (PRODUCT CODE 5886.15.510, LOT #1304835 - STER. 1300165) - PRODUCT NOT SOLD IN THE US. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2014. PATIENT IS A MALE. IT WAS REPORTED HE IS SEDENTARY AND HAS AN AVERAGE BMI. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2022. THE REASON FOR THE REVISION WAS THAT THE LINER #M FOR MOBILE LINER Ø40 (PRODUCT CODE 5885.09.040, LOT #1400499 - STER. (B)(6) HAD MOVED. THE FOLLOWING PROSTHESIS' COMPONENTS WERE REVISED: LINER #M FOR MOBILE LINER Ø40 (PRODUCT CODE 5885.09.040, LOT #1400499 - STER. (B)(6). DELTA ANGLED SPACER 20°# L (PRODUCT CODE 5886.15.510, LOT #1304835 - STER. (B)(6). - PRODUCT NOT SOLD IN THE US. MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #1310635 - STER. (B)(6) . FEMORAL HEAD MEDIUM DIA.36MM (PRODUCT CODE 5010.09.362, LOT #1110245 - STER. (B)(6). NEW COMPONENTS WERE PLACED IN. PATIENT IS A MALE. IT WAS REPORTED HE IS SEDENTARY AND HAS AN AVERAGE BMI. HIS CLINICAL HISTORY OF HIP SURGERIES IS THE FOLLOWING: · PRIMARY SURGERY TOOK PLACE ON (B)(6) 2012, IN WHICH THE LIMA PROSTHESIS WAS IMPLANTED; · FIRST REVISION SURGERY ON (B)(6) 2013, ALL COMPONENTS ON THE ACETABULAR SIDE WERE REVISED. THE REASON FOR THE REVISION IS NOT KNOWN (NO COMPLAINT FILED); · SECOND REVISION SURGERY ON (B)(6) 2014, THE ACETABULAR SPACER AND LINER WERE REVISED. THE REASON FOR THE REVISION IS NOT KNOWN (NO COMPLAINT FILED); · THIRD REVISION SURGERY ON (B)(6) 2022 (HEREBY REPORTED). EVENT HAPPENED IN (B)(6). NOTE: THE SUSPECTED COMPONENT WAS CHANGED AFTER RECEIVING INSIGHTS ON THE REASON FOR PERFORMING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181334 LINER #M FOR MOBILE LINER Ø40 LINER #M FOR MOBILE LINER DIA.40 LZO LIMACORPORATE S.P.A. 5885.09.040 1400499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R