BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - L Ø36MM

    MDR report key: 8309325 · Received February 6, 2019

    Report

    Report Number
    3008021110-2019-00012
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    January 29, 2019
    Report Date
    June 24, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS FOUND ON: A TOTAL OF 96 MODULAR REVISION HEADS MANUFACTURED WITH LOT#1880622/STER. 1800172. A TOTAL OF 50 LINERS MANUFACTURED WITH LOT# 1810793/STER. 1800248. A TOTAL OF 45 ACETABULAR CUPS MANUFACTURED WITH LOT# 1805218 /STER. 1800147. A TOTAL OF 21 STEMS MANUFACTURED WITH LOT# 1800522/STER. 1800069. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS MANUFACTURED WITH THESE LOTS WERE PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO EXPLANTS NOR X-RAYS AVAILABLE FOR FURTHER INVESTIGATION. THE COMPLAINT SOURCE REPORTED THAT GERM RESPONSIBLE FOR INFECTION IS STILL UNKNOWN. IN CONCLUSION, BASED ON THE VERY FEW INFO RECEIVED, WE CAN ASSUME THAT THE ROOT CAUSE OF THIS CASE OF INFECTION IS LIKELY PATIENT CONDITION RELATED. EVENT NOT PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 11 REVISION SURGERIES DUE TO INFECTION INVOLVING A BIOLOX DELTA MODULAR HEADS BELONGING TO THE FAMILY 5010.42.XXX ON A TOTAL OF MORE THAN 130000. BIOLOX DELTA HEADS SOLD WW SINCE 2004. SPECIFIC REVISION RATE LOWER THAN 0.008%. NONE OF THE CASES WE COULD INVESTIGATE WERE CLASSIFIED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET

    Description of Event or Problem · 0

    REVISION SURGERY OF A TOTAL HIP REPLACEMENT DUE TO INFECTION PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFO REPORTED, FEMORAL HEAD WITH CODE 5010.42.363 LOT#1880622 WAS THE ONLY COMPONENT REPLACED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE PRIMARY SURGERY, A COMPLEX THR FOR DISPLASTIC HIP WAS PERFORMED. PATIENT DATA: PATIENT WAS OBESE AND WITH A HIGH RISK OF PROSTHESIS FAILURE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHART OF THE INVOLVED LOT# (1880622 STER. 1800172), NO PRE-EXISTING ANOMALY WAS FOUND, THUS WE CAN STATE THAT THE INVOLVED COMPONENT HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL PROCEED WITH FURTHER INVESTIGATIONS AND SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OF A TOTAL HIP REPLACEMENT DUE TO INFECTION PERFORMED ON (B)(6) 2019. ONLY THE FEMORAL HEAD WITH CODE 5010.42.363 LOT#1880622 WAS REPLACED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE PRIMARY SURGERY, A COMPLEX THR FOR DYSPLASTIC HIP WAS IMPLANTED. ACCORDING TO THE INFO REPORTED BY THE COMPLAINT SOURCE, THE PATIENT WAS OBESE AND WITH A HIGH RISK OF FAILURE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102356 FEM. MODULAR HEAD - L Ø36MM FEM. MODULAR HEAD - L Ø36MM (LZO JDI KWY KWZ LPH MBL) LZO LIMACORPORATE SPA 5010.42.363 1880622

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention