BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - L 32MM

    MDR report key: 9681215 · Received February 7, 2020

    Report

    Report Number
    3008021110-2020-00008
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 25, 2020
    Report Date
    February 23, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHRS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS DETECTED. THEREFORE, WE CAN ASSUME THAT ALL THE COMPONENTS WITH THE SAME LOT NUMBERS WERE PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. ACCORDING TO OUR RECORDS, AT LEAST 14 OUT OF 41 MODULAR HEADS WITH LOT #1811385 AND STER. 1800324 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. ACCORDING TO OUR RECORDS, AT LEAST 10 OUT OF 29 DELTA PROTRUDED LINERS WITH LOT #1818720 AND STER.1900148 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. NO ADDITIONAL DETAILS 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; 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 5010.09.XXX DUE TO INFECTION IS VERY LOW (B)(4). NO SPECIFIC CORRECTIVE ACTIONS IMPLEMENTED IN RELATION TO THIS CASE. LIMA CORPORATE WILL KEEP MONITORED THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY OF HIP PROSTHESIS DUE TO INFECTION PERFORMED ON (B)(6) 2020. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. DURING REVISION, ONLY THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: 5010.09.323, FEM. MODULAR HEAD - L Ø32MM, LOT#1811385, STER.1800324. 5886.54.160, DELTA PROTR.LINER ØINT 32MM #L, LOT#1818720, STER.1900148. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE INVOLVED LOT#S, NO PRE-EXISTING ANOMALY WAS DETECTED. THEREFORE, WE CAN ASSUME THAT ALL THE COMPONENTS WERE PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OF HIP PROSTHESIS DUE TO INFECTION PERFORMED ON (B)(6) 2020. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. DURING REVISION, ONLY THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: 5010.09.323, FEM. MODULAR HEAD - L Ø32MM, LOT#1811385, STER.1800324, DELTA PROTR.LINER, NOT MARKED IN USA. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143994 FEM. MODULAR HEAD - L 32MM MODULAR FEMORAL HEADS (COCRMO) DIA. 32MM L TAPER 12/14 LPH LIMACORPORATE S.P.A. 5010.09.323 1811385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention