BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA PROTR.LINER ØINT 36MM #L

    MDR report key: 16909588 · Received May 11, 2023

    Report

    Report Number
    3008021110-2023-00048
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 17, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 49 DEVICES MANUFACTURED WITH THE SAME LOT 2223045, STER. 2200297. ACCORDING TO OUR RECORDS, AT LEAST 40 OUT OF 49 PROTRUDED LINERS WITH LOT 2223045 - STER. 2200297 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. THE DEVICE INVOLVED WAS RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. VISUAL INSPECTION OF THE LINER SHOWS BARELY A DAMAGE ON THE TOP. NO VISIBLE DAMAGE OR BENT ISSUES CAN BE SEEN ON THE PEG. FUNCTIONAL TEST WAS PERFORMED ON THE PROTRUDED LINER INVOLVED IN THE CURRENT COMPLAINT AND AN ACETABULAR CUP OF SAME SIZE. PROTRUDED LINER WAS PROPERLY COUPLED TO ACETABULAR CUPS. THE TEST PROVED THAT THE STABILITY OF THE POLY LINER INSIDE THE CUP IS ACHIEVED IF THE ASSEMBLY IS PERFORMED ACCORDING TO THE SURGICAL TECHNIQUE. THEREFORE, WE CAN ASSUME THAT THE POSSIBLE CAUSES FOR THE INTRA-OPERATIVE ISSUE OCCURRED, AND THE NECESSITY OF AN EARLY REVISION SURGERY COULD BE: - EVENTUAL PRESENCE OF SOFT TISSUE/PARTICLES BETWEEN THE CONTACTING SURFACES OF LINER AND CUP. SUCH MATERIAL PREVENTS THE CORRECT COUPLING BETWEEN COMPONENTS DURING THE SURGERY; - OR IT MIGHT BE DUE AN IMPROPER POSITIONING OF THE LINER WHEN LODGED IN THE ACETABULAR CUP. PLEASE NOTE THAT THE PROTRUSION PLANE OF PROTRUDED LINERS MIGHT MISTAKENLY BE TAKEN AS THE REFERENCE PLANE OF THE LINER WHEN SEATED INSIDE THE CUP, INSTEAD OF THE EQUATORIAL PLANE. CONSIDERING THAT: - CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED; NO PRE-EXISTING ON DEVICES MANUFACTURED WITH LOT 2223045. - ON THE FUNCTIONAL TEST PERFORMED; LINER INVOLVED IN THE CURRENT COMPLAINT WAS PROPERLY COUPLED TO ACETABULAR CUP. WE CAN ASSUME THAT THE POSSIBLE CAUSE OF THE EVENT IS EVENTUAL PRESENCE OF SOFT TISSUE/PARTICLES BETWEEN SURFACES THAT PREVENT THE CORRECT COUPLING, OR IT MIGHT BE DUE AN IMPROPER POSITIONING OF THE LINER IN THE CUP (USER ERROR). WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE EVENT. WE CAN CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE OCCURRENCE RATE OF INTRA-OPERATIVE DIFFICULTY IN COUPLING DELTA PROTRUDED LINERS (BELONGING TO THE DEVICE CODES 5886.5X.XXX) TO DELTA ACETABULAR CUPS OR DELTA SPACERS IS 0.02% (WW). AS CORRECTIVE ACTION CAPA WITH REF. (B)(4) WAS OPENED, WHICH INCLUDES TRAINING ADDRESSED TO PRODUCT MANAGERS AND SALES REPRESENTATIVES TO FOCUS THE ATTENTION ON STEPS DESCRIBED IN THE SURGICAL TECHNIQUE TO PROPERLY COUPLE PROTRUDED LINERS TO ACETABULAR CUPS. THIS IS AN MDR FINAL REPORT.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE LINERS THAT WERE RELEASED WITH LOT 2223045. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    NTRA-OPERATIVE ISSUE OCCURRED DURING HIP SURGERY ON (B)(6) 2023: DIFFICULTIES IN SEATING THE LINER (CODE 588651260, LOT 2223045, STER. 2200297) INTO THE CUP. ACCORDING TO THE RECEIVED INFORMATION, AFTER MANY ATTEMPTS, IT WAS SEATED STABLY, HOWEVER, UPON X-RAYS CHECK, THE LINER APPEARED LOOSE. REVISION SURGERY WAS THEREFORE PERFORMED. EVENT OCCURRED IN POLAND.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED DURING HIP SURGERY ON (B)(6) 2023: DIFFICULTIES IN SEATING THE LINER (CODE 588651260, LOT 2223045, STER. 2200297) INTO THE CUP. ACCORDING TO THE RECEIVED INFORMATION, AFTER MANY ATTEMPTS, IT WAS SEATED STABLY, HOWEVER, UPON X-RAYS CHECK, THE LINER APPEARED LOOSE. REVISION SURGERY WAS THEREFORE PERFORMED. EVENT OCCURRED IN POLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864210 DELTA PROTR.LINER ØINT 36MM #L PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE LPH LIMACORPORATE S.P.A. 5886.51.260 2223045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention