BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD - M 28MM

    MDR report key: 11855429 · Received May 20, 2021

    Report

    Report Number
    3008021110-2021-00039
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    May 12, 2021
    Report Date
    October 15, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF LOT #1280208, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 30 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 26 OUT OF 30 MODULAR HEADS WITH LOT# 1280208 - STER. 1200183 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF LOT# 1006160, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 10 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 8 OUT OF 10 MET ACETABULAR CUPS WITH LOT #1006160 - STER. 1000225 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF LOT# 1111488, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 32 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, ALL 32 MOBILE LINERS WITH LOT #1111488 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OP REVISION SURGERY. THE X-RAYS RECEIVED - TAKEN IN (B)(6) 2020 - AND A COUPLE OF PICTURES OF THE EXPLANTED ITEMS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "FROM THE SENT PICTURES IT STILL IS UNCLEAR WHAT MIGHT BE THE REASON FOR GROIN PAIN. THE X-RAY SHOWS A PERFECTLY FIXED IMPLANT. ON THE PHOTO OF THE METAL SHELL THERE MIGHT BE SOME SPOTS WITH INCONGRUENT SURFACE INDICATING KIND OF SCRATCHES AND METALLOSIS, BUT THAT PROBABLY IS DUE TO INCOMPLETE CLEANING FROM RESIDUAL BLOOD. IN SUCH CASES WE ALWAYS FIRST OF ALL CHECK THE LUMBAR SPINE, AS GROIN PAIN MAY ALSO BE CAUSED BY NERVAL COMPRESSION OF THE L4/5 SEGMENT. I DO NOT BELIEVE THE IMPLANTS MIGHT BE BLAMED". CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1280208, LOT# 1006160 AND LOT# 1111488; · ACCORDING TO THE MEDICAL EXPERT'S OPINION, THE IMPLANT IS WELL FIXED; WE CANNOT DETERMINE WITH CERTAINTY THE CAUSE OF GROIN PAIN, HOWEVER WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF MODULAR HEADS - BELONGING TO THE FAMILY CODES 5010.42.XXX - DUE TO PAIN IS (B)(4). 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.

    Description of Event or Problem · 0

    REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6), 2021 DUE TO PATIENT EXPERIENCING GROIN PAIN. ACCORDING TO THE COMPLAINT SOURCE, PAIN ONSET STARTED IN (B)(6) 2020. IT WAS REPORTED THAT SURGEON WAS NOT SURE WHAT PAIN'S REASON WAS. THE FOLLOWING COMPONENTS WERE EXPLANTED: · FEMORAL MODULAR HEAD - M Ø28MM (PRODUCT CODE 5010.42.282, LOT# 1280208 - STER. 1200183). · MET ACETABULAR CUP Ø56 (PRODUCT CODE 5544.11.560, LOT# 1006160 - STER. 1000225) - PRODUCT NOT SOLD IN THE US. · MOBILE LINER ØINT 28 MM Ø50 MM (PRODUCT CODE 5566.50.500, LOT# 1111488) - PRODUCT NOT SOLD IN THE US. NEW COMPONENTS WERE IMPLANTED. STEM WAS LEFT IN SITU. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2012. PATIENT IS A FEMALE, 70 YEARS OLD. IT WAS REPORTED THAT EXACT BMI IS NOT KNOWN, HOWEVER THE PATIENT IS OVERWEIGHT. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    CHECKING THE MANUFACTURING CHARTS OF THE LOT #S INVOLVED IN THE COMPLAINT, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6) 2021 DUE TO PATIENT EXPERIENCING GROIN PAIN. ACCORDING TO THE COMPLAINT SOURCE, PAIN ONSET STARTED IN (B)(6) 2020. IT WAS REPORTED THAT SURGEON WAS NOT SURE WHAT PAIN'S REASON WAS. THE FOLLOWING COMPONENTS WERE EXPLANTED: FEMORAL MODULAR HEAD - M Ø28MM (PRODUCT CODE 5010.42.282, LOT# 1280208 - STER. 1200183). MET ACETABULAR CUP Ø56 (PRODUCT CODE 5544.11.560, LOT# 1006160 - STER. 1000225) - PRODUCT NOT SOLD IN US. MOBILE LINER ØINT 28 MM Ø50 MM (PRODUCT CODE 5566.50.500, LOT# 1111488) - PRODUCT NOT SOLD IN US. NEW COMPONENTS WERE IMPLANTED. STEM WAS LEFT IN SITU. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2012. PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750693 FEMORAL MODULAR HEAD - M 28MM BIOLOX DELTA HEAD 28MM #M LZO LIMACORPORATE S.P.A. 5010.42.282 1280208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other