BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - M Ø36MM

    MDR report key: 8163583 · Received December 14, 2018

    Report

    Report Number
    3008021110-2018-00117
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    December 7, 2018
    Report Date
    August 28, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF DHR: BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT# (1881248), NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 190 CERAMIC FEMORAL HEADS MANUFACTURED WITH THE SAME LOT#. NO OTHER COMPLAINTS REPORTED ON THE SAME LOT#. NO EXPLANTS NOR X-RAYS RECEIVED BY LIMACORPORATE. ACCORDING TO THE INFO RECEIVED BY THE COMPLAINT SOURCE THE IMMEDIATE REVISION SURGERY WAS CAUSED BY QUALIFIED STAFF TO MISS THE INCORRECT IMPLANT SIZE. CASE NOT PRODUCT RELATED. PMS DATA: NO OTHER SIMILAR EVENTS REPORTED TO LIMACORPORATE ON A TOTAL OF ABOUT 153615 CERAMIC FEMORAL HEADS BELONGING TO THE FAMILY 5010.42.XXX SOLD WW SINCE 2004. THIS GIVES A SPECIFIC LOW REVISION RATE OF 0.0007%. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON THE (B)(6) 2018 TO REPLACE A CERAMIC FEMORAL HEAD WITH INCORRECT SIZE PREVIOUSLY IMPLANTED. IN DETAILS, PREVIOUS SURGERY TOOK PLACE ON THE 5TH OF DECEMBER 2018. EVEN IF THE SURGICAL PLAN WAS TO IMPLANT A 32MM CERAMIC HEAD, A 36MM CERAMIC HEAD (CODE 5010.42.362 AND LOT# 1881248) WAS MISTAKENLY TAKEN BY THE SURGICAL STAFF AND IMPLANTED. THE SIZE ERROR WAS NOTED ONLY DURING THE FOLLOWING MORNING AFTER SURGERY, FROM THE POST-OP X-RAYS TAKEN (NOT RECEIVED BY LIMACORPORATE). CONSEQUENTLY, IMMEDIATE REVISION SURGERY WAS NECESSARY. DURING THE REVISION SURGERY, THE CORRECT FEMORAL HEAD SIZE (DIA. 32MM) WAS IMPLANTED: SURGEON SATISFIED WITH THE FINAL STABILITY OF THE IMPLANT. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    WE WILL PROCEED WITH FURTHER INVESTIGATION AND SUBMIT A FINAL MDR ONCE CONCLUDED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2018 TO REPLACE THE FEMORAL HEAD WITH INCORRECT SIZE PREVIOUSLY IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018, THE PLAN WAS TO IMPLANT A 32MM CERAMIC HEAD. INSTEAD, A 36MM HEAD (CODE (B)(4) AND LOT# 1881248) WAS MISTAKENLY TAKEN BY THE SURGICAL STAFF AND IMPLANTED. THIS ERROR WAS NOT NOTED UNTIL THE FOLLOWING MORNING AFTER SURGERY, FROM THE POST-OP X-RAY. CONSEQUENTLY REVISION SURGERY WAS NECESSARY. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004051 FEM. MODULAR HEAD - M Ø36MM FEM. MODULAR HEAD - M Ø36MM (LZO JDI KWY KWZ LPH MBL) LZO LIMACORPORATE SPA 5010.42.362 1881248

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention