BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE LINER ØINT 28 MM Ø40 MM

    MDR report key: 15649298 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00097
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 27, 2022
    Report Date
    February 7, 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 STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS STERILIZED WITH THE SAME LOT #S. WE 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 STERILIZED WITH THE SAME LOT #S. ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT RETURNED TO LIMACORPORATE FOR ANALYSIS. LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2022 - AND A COUPLE OF PICTURES OF THE EXPLANTED DEVICES HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE SENT X-RAYS SHOW AN OBVIOUSLY LOOSE CUP WITH A MAJOR BONE DEFECT. WHEN YOU SAY THERE HAS BEEN A BACTERIAL INFECTION THERE IS REASON ENOUGH FOR A SEPTIC LOOSENING. THERE MIGHT HAVE BEEN FAILURES IN IMPLANTING THE CUP ADDITIONALLY, HOWEVER, TO COMMENT ON THAT I WOULD NEED TO SEE THE IMMEDIATE POSTOPERATIVE X-RAY. IN ANY CASE THERE IS NOTHING THAT COULD BE BLAMED ON THE DELTA CUP ITSELF". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S - STER.; · ACCORDING TO THE RECEIVED INFORMATION, SPECIMEN WAS TAKEN DURING SURGERY, HOWEVER THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN; · ACCORDING TO THE MEDICAL CONSULTANT "THE SENT X-RAYS SHOW AN OBVIOUSLY LOOSE CUP WITH A MAJOR BONE DEFECT. WHEN YOU SAY THERE HAS BEEN A BACTERIAL INFECTION THERE IS REASON ENOUGH FOR A SEPTIC LOOSENING"; WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, HOWEVER WE CAN STATE THAT IT WAS NOT PRODUCT RELATED. PMS DATA PMS DATA HAVE BEEN ANALYZED ON THE DELTA REVISION TT CUP AND THE COMPONENT IS NOT SOLD IN THE US. 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 SEPTEMBER 27TH, 2022, DUE TO INFECTION. IT WAS REPORTED THAT THE DELTA-REVISION-TT ACETABULAR CUP Ø58MM (PRODUCT CODE 5533.38.058, LOT #1903336 - STER. 1900134 - PRODUCT NOT SOLD IN THE US) IS LOOSE. THE FOLLOWING COMPONENTS WERE REMOVED: · DELTA-REVISION-TT ACETABULAR CUP Ø58MM (PRODUCT CODE 5533.38.058, LOT #1903336 - STER. 1900134) - PRODUCT NOT SOLD IN THE US. · MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #20AT0Y7 - STER. 2000235) LINER #M FOR MOBILE LINER Ø40 (PRODUCT CODE 5885.09.040, LOT #2010884 - STER. 2000247). DELTA ANGLED SPACER 20°# L+5 (PRODUCT CODE 5886.15.520, LOT #2001837 - STER. 2000124) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2006414 - STER. 2000209). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2011124 - STER. 2000235). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2011592 - STER. 2000239). BONE SCREW Ø6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT #1814190 - STER. 1800311). ACCORDING TO THE RECEIVED INFORMATION, SPECIMEN WAS TAKEN DURING SURGERY, HOWEVER THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. IT WAS REPORTED IT IS A TWO-STAGE REVISION SURGERY WITH CEMENT SPACER IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. IT WAS A REVISION OF A COMPETITOR'S PROSTHESIS, HOWEVER NO FURTHER INFORMATION IS AVAILABLE ON IT. PATIENT IS A MALE. EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. IT WAS REPORTED THAT THE DELTA-REVISION-TT ACETABULAR CUP Ø58MM (PRODUCT CODE 5533.38.058, LOT #1903336 - STER. 1900134 - PRODUCT NOT SOLD IN THE US) IS LOOSE. THE FOLLOWING COMPONENTS WERE REMOVED: · DELTA-REVISION-TT ACETABULAR CUP Ø58MM (PRODUCT CODE 5533.38.058, LOT #1903336 - STER. 1900134) - PRODUCT NOT SOLD IN THE US · MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #20AT0Y7 - STER. 2000235) · LINER #M FOR MOBILE LINER Ø40 (PRODUCT CODE 5885.09.040, LOT #2010884 - STER. 2000247) · DELTA ANGLED SPACER 20°# L+5 (PRODUCT CODE 5886.15.520, LOT #2001837 - STER. 2000124) - PRODUCT NOT SOLD IN THE US · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2006414 - STER. 2000209) · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2011124 - STER. 2000235) · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2011592 - STER. 2000239) · BONE SCREW Ø6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT #1814190 - STER. 1800311) ACCORDING TO THE RECEIVED INFORMATION, SPECIMEN WAS TAKEN DURING SURGERY, HOWEVER THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. IT WAS REPORTED IT IS A TWO-STAGE REVISION SURGERY WITH CEMENT SPACER IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON DECEMBER 9TH, 2021. IT WAS A REVISION OF A COMPETITOR'S PROSTHESIS, HOWEVER NO FURTHER INFORMATION IS AVAILABLE ON IT. PATIENT IS A MALE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241664 MOBILE LINER ØINT 28 MM Ø40 MM MOBILE LINER DIA.INT.28MM DIA.EXT.40MM LZO LIMACORPORATE S.P.A. 5566.50.401 20AT0Y7

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention