BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA PROTRUDED LINER ØINT 28MM #S

    MDR report key: 17123580 · Received June 14, 2023

    Report

    Report Number
    3008021110-2023-00076
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 13, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 1922993, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) OUT OF (B)(4) PROTRUDED LINERS WITH LOT#: 1922993 AND STER. 2000021 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 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#: 1922993, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PLEASE NOTE THAT THE EVENT IS DUE TO DISLOCATION OF THE FEMORAL HEAD, WHICH IS FROM ANOTHER MANUFACTURER. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF DELTA PROTRUDED LINERS BELONGING TO THE FAMILY CODES: 5886.50.XXX AND 5886.51.XXX DUE TO DISLOCATION IS 0.01%. 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 REPORT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO DISLOCATION OF THE FEMORAL HEAD (DIFFERENT MANUFACTURER) FROM THE DELTA PROTRUDED LINER ØINT 28MM #S (PRODUCT CODE: 5886.51.055, LOT#: 1922993 - STER. 2000021). IT WAS REPORTED THAT THE REASON FOR THE DISLOCATION IS NOT KNOWN. THE FOLLOWING COMPONENTS WERE EXPLANTED: DELTA PROTRUDED LINER ØINT 28MM #S (PRODUCT CODE: 5886.51.055, LOT#: 1922993 - STER. 2000021). DELTA-TT ACETABULAR CUP Ø48 MM (PRODUCT CODE: 5552.15.480, LOT#: 1920186 - STER. 2000023). A DELTA MULTIHOLE TT CUP 52MM WAS IMPLANTED WITH A DUAL MOBILITY LINER AND LIMAVIT LINER. THE ORIGINAL PROSTHESIS HAD THE FEMORAL STEM AND THE FEMORAL HEAD FROM ANOTHER MANUFACTURER THAT WERE REIMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. PATIENT IS A FEMALE, 72 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874845 DELTA PROTRUDED LINER ØINT 28MM #S PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 28MM - SIZE SMALL LPH LIMACORPORATE S.P.A. 5886.51.055 1922993

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention