BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK BIPOL.SELF-CENT.HEAD 49

    MDR report key: 10275166 · Received July 15, 2020

    Report

    Report Number
    3008021110-2020-00052
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    July 13, 2020
    Report Date
    October 5, 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 DHRS OF THE LOT#S INVOLVED: NO PRE-EXISTING ANOMALY WAS DETECTED ON 25 LOCK BIPOLSELF-CENTHEAD Ø49 MANUFACTURED WITH LOT # 1800864. FIRST AND ONLY COMPLAINT RECEIVED OUT OF 15 ITEMS ALREADY IMPLANTED WITH THIS LOT#. NO PRE-EXISTING ANOMALY WAS DETECTED ON 60 FEMORAL MODULAR HEADS MANUFACTURED WITH LOT #1980035. FIRST AND ONLY COMPLAINT RECEIVED OUT OF 45 ITEMS ALREADY IMPLANTED WITH THIS LOT#. EXPLANTS ANALYSIS: EXPLANTED COMPONENTS WERE RECEIVED IN LIMACORPORATE FOR TECHNICAL INVESTIGATION. BY TECHNICAL INSPECTION, THE C-RING AND LINER DID NOT APPEAR TO BE DAMAGED. TO TEST THE FUNCTIONALITY OF THE POLY C-RING, WE INSERTED IT INTO THE CUP AS PER SURGICAL TECHNIQUE AND WE WERE NOT ABLE TO REMOVE IT, FINDING THAT THE LOCKING SYSTEM WAS STILL FUNCTIONAL. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE FEMORAL HEAD 5010.42.281 AND ON THE METAL CUP OF THE LOCK BIPOLAR HEAD 5527.09.490: NO DIMENSIONAL ANOMALY WAS DETECTED. IT WAS NOT POSSIBLE TO PERFORM ANY DIMENSIONAL ANALYSIS ON THE POLY C-RING AND ON THE POLY LINER BECAUSE THE WASHING AND STERILIZATION PROCESSES SLIGHTLY DEFORMED THEM. CLINICAL ANALYSIS: WE RECEIVED PRE-REVISION XRAYS TAKEN ON (B)(6), 2020, AND SENT THEM TO OUR MEDICAL CONSULTANT FOR CLINICAL INVESTIGATION. FOLLOWING, HIS COMMENT IS REPORTED: "THIS RING OBVIOUSLY HAS DISLOCATED, SUCH ENABLING DISLOCATION OF THE HEAD OUT OF THE POLY. I CANNOT SEE ANY DAMAGE ON THAT RING, MEANING IT EITHER HAS NOT BEEN PLACED CORRECTLY OR THE SYSTEM IS NOT CAPABLE OF AVOIDING DISLOCATION. I SUGGEST EXAMINATION OF THE EXPLANTS TO FIND OUT WHICH ASSUMPTION IS CORRECT. QUALITY CONTROL OF THE SYSTEM SHOULD EVALUATE THE SAFETY OF THE SYSTEM REGARDING UN-LOCKING." BECAUSE DIMENSIONAL ANALYSIS AND FUNCTIONAL TEST DEMONSTRATED THAT THE ENTIRE LOCKING SYSTEM WAS STILL FUNCTIONAL, WE CAN EXCLUDE THAT THE ROOT CAUSE OF DISLOCATION WAS PRODUCT RELATED. WE ARE AWARE THAT PATIENT FELL, BUT WE DO NOT KNOW IF SHE STARTED HAVING PAIN AND LOSS OF FUNCIONALITY AFTER THAT EVENT. MEDICAL EXPERT DID NOT DETECT ANY ANOMALY IN IMPLANT POSITIONING AND ANY DAMAGE OF THE C-RING, THEREFORE WE CAN HYPOTHESIZE THAT DISENGAGING OF THE C-RING WAS DUE TO ITS INITIAL MALPOSITINING COMBINED WITH PATIENT'S FALL. PMS DATA: ACCORDING TO OUR PMS DATA, OCCURRENCE RATE OF DISLOCATION OF THE LOCK BIPOLAR HEAD SYSTEM IS 0.01%. MOST OF THESE CASES WERE DUE TO PATIENT CONDITION/SURGICAL FACTOR. NO CORRECTIVE ACTIONS IMPLEMENTED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED.

    Description of Event or Problem · 0

    PRIMARY SURGERY FOR BIPOLAR HIP PROSTHESIS WAS PERFORMED ON (B)(6) 2019. ONE YEAR LATER (EXACT DATE UNKNOWN), INNER FEMORAL HEAD (PRODUCT CODE 5010.42.281, LOT #1980035, STER.1900035) DISLOCATED FROM LOCK BIPOLAR HEAD (PRODUCT CODE 5527.09.490, LOT #1800864, STER.1800024). FEMORAL HEAD AND LOCK BIPOLAR HEAD WERE REMOVED AND REPLACED (EXACT DATE OF REVISION SURGERY IS UNKNOWN). ACCORDING TO THE INFORMATION PROVIDED BY THE COMPLAINT SOURCE, PATIENT FELL DOWN WHILE VISITING SHRINE OR TEMPLE. HOWEVER, THE SURGEON BELIEVED THAT THE FALL WAS NOT THE ROOT CAUSE OF DISLOCATION. THE PATIENT IS FEMALE, 84 YEARS OLD, BMI OF 20.08. EVENT OCCURRED IN JAPAN.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE LOT#S INVOLVED: NO PRE-EXISTING ANOMALY WAS DETECTED ON 25 LOCK BIPOL.SELF-CENT.HEAD (B)(4) MANUFACTURED WITH LOT # 1800864. FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT. NO PRE-EXISTING ANOMALY WAS DETECTED ON 60 FEMORAL MODULAR HEADS MANUFACTURED WITH LOT #1980035. FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT. WE WILL SUBMIT A FINAL MDR WHEN THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    PRIMARY SURGERY FOR BIPOLAR HIP PROSTHESIS WAS PERFORMED ON (B)(6) 2019. IN ABOUT 1YEAR, INNER HEAD BECAME DISLOCATED FROM BIPOLAR HEAD. DURING REVISION SURGERY, THE FOLLOWING PRODUCTS WERE EXPLANTED: FEM. MODULAR HEAD - S 28MM, PRODUCT CODE 5010.42.281, LOT #1980035, STER.1900035 ; LOCK BIPOL.SELF-CENT.HEAD 49, PRODUCT CODE 5527.09.490, LOT #1800864, STER.1800024. EXACT DATE OF REVISION SURGERY IS UNKNOWN. NO TRAUMA OR FALL REPORTED BY THE PATIENT. THE PATIENT IS FEMALE, (B)(6) YEARS OLD, 153 CM X (B)(6) KG. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741181 LOCK BIPOL.SELF-CENT.HEAD 49 LOCK BIPOL.SELF-CENT.HEAD Ø49 (LPH-JDI-KWY-KWZ) LPH LIMACORPORATE SPA 5527.09.490 1800864

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention