BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK BIPOL.SELF-CENT.HEAD Ø45

    MDR report key: 8825251 · Received July 25, 2019

    Report

    Report Number
    3008021110-2019-00084
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 5, 2019
    Report Date
    February 14, 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

    INVESTIGATION: CHECK OF THE DHR: BY CHECKING THE MANUFACTURING CHART OF THE LOT #1000404, NO ANOMALY WAS FOUND ON A TOTAL OF 16 LOCK BIPOLSELF-CENT. HEAD Ø45 MANUFACTURED WITH THIS LOT#. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THIS LOT#. EXPLANT ANALYSIS: LOCK BIPOLAR HEAD AND FEMURAL MODULAR HEAD WERE RETURNED TO LIMACORPORATE AND EXAMINED. C-RING COMPONENT OF THE BIPOLAR HEAD WAS DETACHED AND APPEARED TO BE WORN ON THE EXTERNAL SURFACE. MATERIAL DETERIORATION COULD HAVE ALLOW DETACHMENT OF THE C-RING AND CONSEQUENTLY HEAD DISLOCATION. XRAYS ANALYSIS: PRE-REVISION XRAYS DATED 01/07/2019 WERE ANALYZED BY OUR MEDICAL CONSULTANT, WHO COMMENTED: "THE LOCK BIPOL.SELF-CENT.HEAD Ø45 WAS IMPLANTED ALREADY IN 2010. IT WOULD BE IMPORTANT TO CONFIRM, THAT THE DETACHMENT OCCURED IN 2019 AND NOT ALREADY BEFORE. IF IT HAPPENED 9 YRS AFTER IMPLANTATION IT MAY BE A "NORMAL" CONSEQUENCE OF AGING. IF IT WAS ALREADY BEFORE THERE MIGHT BE SOME MISTAKE OF THE SURGEON IN CONNECTING THE PARTS". AS OUR MEDICAL CONSULTANT STATED, AGING OF THE MATERIAL IS A NORMAL CONSEQUENCE 9 YEARS AFTER IMPLANTATION. EVEN IF IT IS UNKNOWN WHEN THE DISENGAGEMENT WAS EXACTLY HAPPEND, WE CAN REASONABLY SUPPOSE THAT LIFTING THE LUGGAGE CAUSED HEAD DISLOCATION. IN CONCLUSION, STATING THAT NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE DHR AND CONSIDERING OUR MEDICAL CONSULTANT OPINION, 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

    REVISION SURGERY DUE TO DISLOCATION PERFORMED ON (B)(6) 2019. C-RING OF THE LOCK BIPOLAR HEAD CODE 5527.09.450 LOT #1000404 WAS DETACHED FROM THE BIPOLAR CUP, CONSEQUENTLY BIPOLAR CUP AND FEMORAL HEAD WERE EXPLANTED. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT HAD LOW ACTIVITY LEVEL AND SHE FELT HURT WHILE SHE WAS LIFTING A LUGGAGE. THE PATIENT IS FEMALE, 63 YEARS OLD, 155 CM HEIGHT AND 36 KG WEIGHT. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010. EVENT HAPPENED IN JAPAN.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHART OF THE LOT #1000404, NO ANOMALY WAS FOUND ON A TOTAL OF 16 LOCK BIPOLSELF-CENTHEAD Ø45 MANUFACTURED WITH THIS LOT. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED INVOLVING THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO DISLOCATION PERFORMED ON (B)(6) 2019. C RING WAS DETACHED FROM THE BIPOLAR CUP, THEREFORE LOCK BIPOL.SELF-CENT.HEAD Ø45 CODE 5527.09.450 LOT #1000404 WAS EXPLANTED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010. ACCORDING TO THE INFO REPORTED, THE PATIENT HAD LOW ACTIVITY LEVEL AND SHE FELT HURT WHILE SHE WAS LIFTING A LUGGAGE. THE PATIENT IS FEMALE, (B)(6) YEARS OLD, 155 CM HEIGHT AND (B)(6) WEIGHT. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618790 LOCK BIPOL.SELF-CENT.HEAD Ø45 LOCK BIPOL.SELF-CENT.HEAD Ø45 (LPH-JDI-KWY-KWZ ) LPH LIMACORPORATE SPA 5527.09.450 1000404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention