BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - S 36MM

    MDR report key: 11453020 · Received March 10, 2021

    Report

    Report Number
    3008021110-2021-00015
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 10, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. ACCORDING TO OUR RECORDS, AT LEAST 16 OUT OF 22 MINIMA S STEM WITH LOT #2001859 - STER. 2000152 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. ACCORDING TO OUR RECORDS, AT LEAST 69 OUT OF 100 MODULAR HEADS WITH LOT #2082487 - STER. 2000345 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. ACCORDING TO OUR RECORDS, AT LEAST 9 OUT OF 18 DELTA NEUTRAL LINERS WITH LOT #1921569 - STER. 2000181 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. NO ADDITIONAL DETAILS ARE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; EXPLANTED COMPONENTS; GERM RESPONSIBLE FOR THE INFECTION. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE CHECK OF THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, THE REVISION RATE OF MODULAR HEADS WITH CODES 5010.42.XXX DUE TO INFECTION IS VERY LOW (0,01%). NO SPECIFIC CORRECTIVE ACTIONS IMPLEMENTED IN RELATION TO THIS CASE. LIMA CORPORATE WILL KEEP MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO INFECTION. ACCORDING TO THE COMPLAINT SOURCE, THE ORIGINAL SURGEON'S PLAN WAS FOR THE FEMORAL HEAD AND LINER TO BE EXCHANGED DUE TO INFECTION. ONCE THE FEMORAL HEAD WAS BEING REMOVED, THE STEM BECAME LOOSE AND WAS ALSO REMOVED. TO SUMMARIZE, THE FOLLOWING COMPONENTS WERE EXPLANTED AND EXCHANGED: MINIMA S STANDARD STEM #6 (PRODUCT CODE 4503.21.060, LOT# 2001859 - STER.2000152); FEMORAL MODULAR HEAD - S Ø36MM (PRODUCT CODE 5010.42.361, LOT# 2082487 - STER.2000345); DELTA NEUTRAL LINER D.36MM #M+ (PRODUCT CODE 5885.54.259, LOT# 1921569 - STER.2000181). IT WAS REPORTED THAT A WASH OUT OF THE JOINT WAS PERFORMED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353895 FEM. MODULAR HEAD - S 36MM BIOLOX DELTA HEAD 36MM #S LZO LIMACORPORATE S.P.A. 5010.42.361 2082487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention