BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR STEM Ø16MM

    MDR report key: 14771989 · Received June 22, 2022

    Report

    Report Number
    3008021110-2022-00054
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    June 14, 2022
    Report Date
    October 20, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PROCESSED WITH THOSE STERILIZATION #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S/STER. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PROCESSED WITH THOSE STERILIZATION #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S/STER. EXPLANTS ANALYSIS: THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - TAKEN IN APRIL 2022 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "WHEN YOU SAY THE REVISION JAN.22 HAS BEEN ONLY 1 MONTH AFTER THE PRIMARY IMPLANTATION IT MAY BE PRESUMED, THAT THE INDICATION ALREADY WAS INFECTION. BESIDE THAT ONLY SEVERE FAILURE OF SURGERY MAY BE SUSPECTED. THE SURGEON REPLACED A (PRESUMABLY CEMENTED) STEM WITH THE LIMA UNCEMENTED REVISION SYSTEM. FROM THE 3 CERCLAGE BANDS IN PLACE, IT MAY BE CONCLUDED THAT THE SURGEON HAD TO USE A TRANSFEMORAL APPROACH FOR REMOVING THE PRIMARY STEM. THIS IS A QUITE EXTENSIVE PROCEDURE WITH A LOT OF TISSUE DAMAGE. WHEN THE REIMPLANTATION HAS BEEN DONE INTO AN INFECTED SITE WITHOUT ADDITIONAL MEASURES AND LEAVING THE CEMENTED CUP IN PLACE, IT IS NOT SURPRISING, THAT SOME WEEKS LATER INFECTION RE-OCCURS, FINALLY LEADING TO REMOVAL OF THE IMPLANTS IN JUNE. IMPLANTATION OF AN AB LOADED SPACER IS QUITE COMMON IN SUCH INDICATIONS. THE SENT XRAY, DATED APRIL, SHOWS A CORRECTLY IMPLANTED HYBRID PROSTHESIS. NO SIGN OF LOOSENING OR IMPLANT FAILURE. WHAT I FIND SOMEHOW UNUSUAL IS THE AMOUNT OF NEWLY FORMED BONE AT THE FEMUR. I DO NOT BELIEVE SUCH EXTENSIVE BONE GROWTH MAY BE POSSIBLE WITHIN ONLY 3 MONTHS, HOWEVER, THAT APPEARANCE MAKES NO DIFFERENCE IN THE NECESSITY OF REMOVING AN INFECTED IMPLANT. HAS THE HIP BEEN REIMPLANTED MEANWHILE?". WHETHER THE HIP HAD BEEN REIMPLANTED WAS FURTHER ASKED TO THE COMPLAINT SOURCE, HOWEVER NO INFORMATION WAS AVAILABLE. CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S/STER; · ACCORDING TO THE REPORTED INFORMATION, THE REASON FOR THE FIRST REVISION SURGERY IS NOT KNOWN; · ACCORDING TO THE MEDICAL EXPERT'S OPINION "[...] THE REVISION JAN.22 HAS BEEN ONLY 1 MONTH AFTER THE PRIMARY IMPLANTATION IT MAY BE PRESUMED, THAT THE INDICATION ALREADY WAS INFECTION. BESIDE THAT ONLY SEVERE FAILURE OF SURGERY MAY BE SUSPECTED", AND "IT MAY BE CONCLUDED THAT THE SURGEON HAD TO USE A TRANSFEMORAL APPROACH FOR REMOVING THE PRIMARY STEM. THIS IS A QUITE EXTENSIVE PROCEDURE WITH A LOT OF TISSUE DAMAGE. WHEN THE REIMPLANTATION HAS BEEN DONE INTO AN INFECTED SITE WITHOUT ADDITIONAL MEASURES AND LEAVING THE CEMENTED CUP IN PLACE, IT IS NOT SURPRISING, THAT SOME WEEKS LATER INFECTION RE-OCCURS, FINALLY LEADING TO REMOVAL OF THE IMPLANTS IN JUNE"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF REVISION STEMS - BELONGING TO THE FAMILY CODES 38XX.15.0XX - DUE TO INFECTION IS 0.013%. 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 REPORT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. ACCORDING TO THE COMPLAINT SOURCE, THE RESULTS FROM SPECIMEN ANALYSIS WERE NOT AVAILABLE. THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. ALL IMPLANTS WERE REMOVED: REVISION MODULAR STEM Ø16MM (PRODUCT CODE 3812.15.010, LOT #2022340 - STER. 2100003). FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.42.362, LOT #1980629 - STER. 1900245). REVISION LATERALIZED NECK H.60MM (PRODUCT CODE 7515.15.110, LOT #1908759 - STER. 1900267). A SPACER WAS PLACED IN. PATIENT IS A MALE, 69 YEARS OLD. HISTORY OF HIP SURGERIES IS THE FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6) 2021. COMPETITOR'S IMPLANTS PLACED IN; FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2022. COMPETITOR'S FEMORAL COMPONENTS WERE EXPLANTED AND REPLACED BY LIMA'S DEVICES ABOVEMENTIONED. THE REASON FOR REVISION IS NOT KNOWN; SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO INFECTION (HEREBY REPORTED). EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6)2022, DUE TO INFECTION. ACCORDING TO THE COMPLAINT SOURCE, THE RESULTS FROM SPECIMEN ANALYSIS WERE NOT AVAILABLE. THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. ALL IMPLANTS WERE REMOVED: · REVISION MODULAR STEM Ø16MM (PRODUCT CODE 3812.15.010, LOT #2022340 - STER. 2100003) · FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.42.362, LOT #1980629 - STER. 1900245) · REVISION LATERALIZED NECK H.60MM (PRODUCT CODE 7515.15.110, LOT #1908759 - STER. 1900267) A SPACER WAS PLACED IN. PATIENT IS A MALE, 69 YEARS OLD. HISTORY OF HIP SURGERIES IS THE FOLLOWING: - PRIMARY SURGERY PERFORMED ON (B)(6)2021. COMPETITOR'S IMPLANTS PLACED IN; - FIRST REVISION SURGERY TOOK PLACE ON (B)(6)2022. COMPETITOR'S FEMORAL COMPONENTS WERE EXPLANTED AND REPLACED BY LIMA'S DEVICES ABOVEMENTIONED. THE REASON FOR REVISION IS NOT KNOWN; - SECOND REVISION SURGERY TOOK PLACE ON (B)(6)2022, DUE TO INFECTION (HEREBY REPORTED). EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624738 REVISION MODULAR STEM Ø16MM REVISION STEM DIA. 16 MM, L. 140 MM LZO LIMACORPORATE S.P.A. 3812.15.010 2022340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other