BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADS Ø28 COCRMO - UHMWPE

    MDR report key: 8513208 · Received April 15, 2019

    Report

    Report Number
    3008021110-2019-00038
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 11, 2019
    Report Date
    February 17, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE DHR OF THE INVOLVED LOT#S: - NO PRE-EXISTING ANOMALY WAS DETECTED ON (B)(4) BIPOLAR HEAD + LINER DIA.36MM MANUFACTURED WITH THE SAME LOT#. NO OTHER COMPLAINTS RECEIVED ON THIS LOT#; - NO PRE-EXISTING ANOMALY WAS DETECTED ON (B)(4) COCRMO MODULAR HEAD MANUFACTURED WITH THE SAME LOT#. NO OTHER COMPLAINTS RECEIVED ON THIS LOT#. XRAYS ANALYSIS: XRAYS WERE NOT AVAILABLE FOR INVESTIGATION. EXPLANTS ANALYSIS: LOCK BIPOLAR HEAD AND FEMURAL MODULAR HEAD WERE RETURNED TO LIMACORPORATE AND EXAMINED. VISUAL INSPECTION SHOWED C-RING COMPONENT OF THE BIPOLAR HEAD WAS DETACHED AND APPEARED TO BE WORN ON THE EXTERNAL SURFACE. MATERIAL DETERIORATION DUE TO NORMAL AGING OF THE PRODUCT (OCCURRED 9 YEARS AFTER PRODUCT IMPLANT) COULD HAVE ALLOW DETACHMENT OF THE C-RING AND CONSEQUENTLY HEAD DISLOCATION. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO INVESTIGATE THE ROOT CAUSE OF THE EVENT. PATIENT INFORMATION SUCH AS WEIGHT/BMI/ACTIVITY LEVEL/XRAYS ARE MANDATORY TO INVESTIGATE THIS TYPE OF EVENT. HOWEVER, STATING THAT NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE DHR AND THE EVENT OCCURRED 9 YEARS AFTER IMPLANTATION, WE CAN HYPOTHESIZE THAT THE EVENT IS DUE NORMAL AGING OF THE PRODUCT. PMS DATA: ON THE BASIS OF PMS DATA, REVISION RATE DUE TO DISLOCATION OF LOCK BIPOLAR HEAD SYSTEM IS 0,013%. NONE OF THESE CASES WAS JUDGED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS FOR THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISLOCATION PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON (B)(6) 2010. DURING SURGERY, IT WAS NOTED THAT THE RING OF LOCK SELF-CENTERING HEAD WAS DISENGAGED. THE SURGEON TRIED TO ATTACH THE RING TO THE CUP, BUT THE RING BECAME LOOSENED AND COULD NOT BE ATTACHED. THE LOCK SELF-CENTERING HEAD (CODE #5527.09.460 LOT #0903280) AND THE MODULAR HEAD (CODE #5010.09.282 LOT #0908561) WERE REPLACED. EVENT OCCURRED IN JAPAN.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALIES WERE FOUND. THIS IS THE FIRST AND ONLY COMPLAINT INVOLVING THESE LOT #S. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO DISLOCATION PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON (B)(6) 2010. DURING SURGERY, IT WAS NOTED THAT THE RING OF LOCK SELF-CENTERING HEAD WAS DISENGAGED. THE SURGEON TRIED TO ATTACH THE RING TO THE CUP, BUT THE RING BECAME LOOSENED AND IT COULD NOT BE ATTACHED. THE LOCK SELF-CENTERING HEAD (CODE #5527.09.460, LOT #0903280) AND THE MODULAR HEAD (CODE #5010.09.282, LOT #0908561) WERE REPLACED. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306427 HEADS Ø28 COCRMO - UHMWPE LOCK BIPOL.SELF-CENT.HEAD Ø46 (LPH-JDI-KWY-KWZ) LPH LIMACORPORATE SPA 5527.09.460 0903280

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention