BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEADS

    MDR report key: 18976855 · Received March 26, 2024

    Report

    Report Number
    3008021110-2024-00029
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    February 28, 2024
    Report Date
    June 7, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF INVOLVED LOT NUMBERS, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THOSE LOT NUMBERS. THEREFORE, ALL THE PRODUCTS WITH THOSE LOT NUMBERS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT NUMBERS INVOLVED. EVEN THOUGH REQUESTED THE FOLLOWING INFORMATION WAS NOT RECEIVED BY THE COMPLAINT SOURCE: - PRE- AND POST-OPERATIVE X-RAYS?; - PATIENT'S CLINICAL DATA ; - PATHOGEN RESPONSIBLE FOR INFECTION; - PHOTOS OF THE EXPLANTS. WITHOUT THE POSSIBILITY TO ANALYZE ADDITIONAL INFORMATION, NO DEEP ANALYSIS CAN BE PERFORMED, THEREFORE WE CANNOT DETERMINE THE CAUSE OF THE INFECTION. NEVERTHELESS, THE CHECK OF THE STERILIZATION CHARTS CONFIRMED THAT THE DEVICES INVOLVED WERE REGULARLY STERILIZED, NO ANOMALY DETECTED. IN CONCLUSION, IT SEEMS THAT THE INFECTION WAS CAUSED BUT EXTERNAL FACTORS NOT RELATED TO THE PRODUCTS. PMS DATA. BASED ON LIMACORPORATE'S PMS DATA, WE ESTIMATE A REVISION RATE OF THE FEMORAL HEADS BELONGING TO FAMILY CODES 5010.09.XXX DUE TO INFECTION OF ABOUT (B)(4)%. NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANYFURTHER SIMILAR EVENT. THIS IS AN MDR FINAL REPORT.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF INVOLVED LOT NUMBERS, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THOSE LOT NUMBERS. THEREFORE, ALL THE PRODUCTS WITH THOSE LOT NUMBERS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO SEPTIC LOOSENING. SPACER WITH ANTIBIOTIC WAS USED. PREVIOUS REVISION PERFORMED ON (B)(6) 2018. PATIENT AGE: 76 YEARS OLD. THE FOLLOWING DEVICES WERE EXPLANTED: FEM. MODULAR HEAD - S Ø28MM (PRODUCT CODE: 5010.09.281, LOT.1802026 - STER. 1800078). DELTA-PF ACETAB.CUP Ø46 MM (PRODUCT CODE: 5551.25.460, LOT. 1700825 - STER. 1700078) - - NOT SOLD IN US. DELTA PROTR.LINER ØINT 28MM #S (PRODUCT CODE: 5886.51.055, LOT. 1712008 - STER. 1700322). ANOTHER DEVICE GREAT-S PL3 HIP - STEM #3 H=144MM (PRODUCT CODE: 4520HA030 - LOT. 1705832) MANUFACTURED BY HIT MEDICA S.P.A. WAS ALSO EXPLANTED. EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO SEPTIC LOOSENING. SPACER WITH ANTIBIOTIC WAS USED. THE FOLLOWING DEVICES WERE EXPLANTED: · FEM. MODULAR HEAD - S Ø28MM (PRODUCT CODE: 5010.09.281, LOT.1802026 - STER. (B)(4)) · DELTA-PF ACETAB.CUP Ø46 MM (PRODUCT CODE: 5551.25.460, LOT. 1700825 - STER. (B)(4)) - NOT SOLD IN US · DELTA PROTR.LINER ØINT 28MM #S (PRODUCT CODE: 5886.51.055, LOT. 1712008 - STER. (B)(4)) PREVIOUS REVISION PERFORMED ON (B)(6) 2018. PATIENT AGE: 76 YEARS OLD EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11092 MODULAR HEADS MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM S TAPER 12/14, LPH LIMACORPORATE S.P.A. 5010.09.281 1802026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention