BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-TT ACETABULAR CUP Ø54 MM

    MDR report key: 16778030 · Received April 20, 2023

    Report

    Report Number
    3008021110-2023-00042
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 30, 2023
    Report Date
    April 19, 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 #2112653, 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) ACETABULAR CUPS WITH LOT #2112653 - STER. 2100219 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. 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: CLINICAL DATA FOR THE PATIENT; X-RAYS RELATED TO THE REVISION SURGERY. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #2112653; ACCORDING TO THE REPORTED INFORMATION, THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY STATED THAT THE INSTABILITY WAS DUE TO THE SUBOPTIMAL VERSION OF THE STEM; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF DELTA TT ACETABULAR CUPS - BELONGING TO THE FAMILY CODES 5552.15.XXX - DUE TO INSTABILITY 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 WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO IMPLANT INSTABILITY. ACCORDING TO THE RECEIVED INFORMATION, THE VERSION OF THE STEM WASN'T IDEAL ACCORDING TO THE SURGEON OPERATING THE REVISION SURGERY. THE FOLLOWING COMPONENTS GOT EXPLANTED: DELTA-TT ACETABULAR CUP Ø54 MM (PRODUCT CODE 5552.15.540, LOT #2112653 - STER. 2100219). DELTA PROTRUDED LINER ØINT 28MM #L (PRODUCT CODE 5886.51.060, LOT #1900491 - STER. 1900035). NEW SIZE 58MM ACETABULAR CUP AND LINER FOR 32MM FEMORAL HEAD WERE IMPLANTED. COMPETITOR'S FEMORAL HEAD AND OFFSET ADAPTOR WERE PLACED IN TO ADJUST THE STEM'S VERSION. THE FEMORAL SIDE IS FROM ANOTHER MANUFACTURER. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE SURGEON RESPONSIBLE FOR THE PREVIOUS SURGERY IS THE SAME WHO OPERATED THE REVISION. NO CLINICAL DATA AVAILABLE FOR THE PATIENT. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590174 DELTA-TT ACETABULAR CUP Ø54 MM ACETABULAR CUPS (TI6AL4V) DIA. 54MM FOR LINER SIZE LARGE LPH LIMACORPORATE S.P.A. 5552.15.540 2112653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown