BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD - XL Ø40MM

    MDR report key: 17487296 · Received August 9, 2023

    Report

    Report Number
    3008021110-2023-00101
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 14, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K182099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 1002148, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 24 OUT OF 35 FEMORAL HEADS WITH LOT#: 1002148 AND STER. 1000216 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT#. DEVICE ANALYSIS: THE ITEM INVOLVED WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE OF THE REVISION SURGERY. THE X-RAY RECEIVED - EXACT DATE UNKNOWN AND A PICTURE OF EXPLANTED FEMORAL HEAD HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE EXPLANTED HEAD LOOKS RATHER STRANGE, HOWEVER, FROM THE PHOTO ALONE I CANNOT MAKE ANY COMMENT. IT REQUIRES EXAMINATION BY A MATERIAL TECHNICIAN. I UNDERSTAND THE IMPLANTS HAVE BEEN IN PLACE FOR 12YRS, WITHOUT ANY REPORTED INCIDENCE. THE DATE OF AMPUTATION OF THE OTHER SIDE IS NOT KNOWN. I PRESUME IT HAS BEEN SHORTLY BEFORE THE REPORTED DISLOCATION. INDEED, THIS WOULD MEAN AN EXTREME ADDITIONAL LOAD ON THE RESPECTIVE JOINT, ESPECIALLY WHEN THE PATIENT IS OBESE. UNDER SUCH CONDITIONS IT IS NOT VERY SURPRISING THAT DISLOCATIONS OR BREAKAGE MAY OCCUR. THE IMPLANTS ON THE X-RAYS SHOW CORRECT PLACEMENT, ALTHOUGH I WOULD HAVE CHOSEN A BIGGER STEM. WITH SURVIVAL OF 12 YRS THIS FEELING IS IRRELEVANT. HOWEVER, I DON'T UNDERSTAND, WHAT MEANS "REPLACED" WITH THE FEMORAL HEAD. ONLY SAME TYPE? KNOWING THAT THERE IS AN INCREASED RISK OF DISLOCATION IT SHOULD HAVE BEEN EXCHANGED TO A DOUBLE MOBILITY VERSION". THE PICTURE OF THE EXPLANTED FEMORAL HEAD SHOWS DAMAGES TO THE SURFACE OF THE DEVICE, HOWEVER THE EXPLANTED DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR FURTHER ANALYSIS. CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT#: 1002148; · ACCORDING TO THE MEDICAL CONSULTANT "THE DATE OF AMPUTATION OF THE OTHER SIDE IS NOT KNOWN. I PRESUME IT HAS BEEN SHORTLY BEFORE THE REPORTED DISLOCATION. INDEED, THIS WOULD MEAN AN EXTREME ADDITIONAL LOAD ON THE RESPECTIVE JOINT, ESPECIALLY WHEN THE PATIENT IS OBESE. UNDER SUCH CONDITIONS IT IS NOT VERY SURPRISING THAT DISLOCATIONS OR BREAKAGE MAY OCCUR"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF BIOLOX FEMORAL HEADS BELONGING TO THE FAMILY CODES 5010.42.XXX DUE TO DISLOCATION IS <0.01%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1002148, NO PRE-EXISTING ANOMALY WERE FOUND ON THE 35 DEVICES MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THAT LOT #. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO DISLOCATION OF THE FEMORAL MODULAR HEAD - XL Ø40MM (PRODUCT CODE: 5010.42.404, LOT#: 1002148 - STER. 1000216). THE FEMORAL HEAD WAS REMOVED ONLY AND REPLACED. THE IMPLANTED NEW FEMORAL HEAD IS FROM A COMPETITOR. IT WAS REPORTED THAT PATIENT IS A FEMALE. SHE'S OBESE AND HER OTHER LEG GOT AMPUTATED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2011. VENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO DISLOCATION OF THE FEMORAL MODULAR HEAD - XL Ø40MM (PRODUCT CODE 5010.42.404, LOT #1002148 - STER. 1000216). THE FEMORAL HEAD WAS REMOVED ONLY AND REPLACED. IT WAS REPORTED THAT PATIENT IS A FEMALE. SHE'S OBESE AND HER OTHER LEG GOT AMPUTATED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2011. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588017 FEMORAL MODULAR HEAD - XL Ø40MM FEMORAL HEADS (BIOLOX®DELTA) DIA. 40MM #XL LPH LIMACORPORATE S.P.A. 5010.42.404 1002148

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention