BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD - M Ø32MM

    MDR report key: 12370023 · Received August 26, 2021

    Report

    Report Number
    3008021110-2021-00068
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 23, 2021
    Report Date
    November 22, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT NUMBERS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT NUMBERS. NO EXPLANTS AVAILABLE TO BE SENT BACK FOR FURTHER ANALYSIS. A SINGLE PRE-OPERATIVE X-RAY (EXACT DATE UNKNOWN) + A SINGLE X-RAY FROM NOVEMBER 2019 WAS RECEIVED FROM THE COMPLAINT SOURCE AND ANALYZED BY LIMA HIP MEDICAL CONSULTANT WITH THE FOLLOWING ASSESSMENT: "ON THE PRE-OP X-RAY A FRACTURE IS VISIBLE ONLY AT THE ACETABULAR FLOOR, WITHOUT MAJOR DISLOCATION. THIS IS NOT UNUSUAL IN CASE OF CUP-LOOSENING AND SHOULD NOT REPRESENT A MAJOR ISSUE IN CASE OF A REVISION. IT MIGHT BE POSSIBLE, THAT FRACTURE ALREADY HAS OCCURRED DURING THE PRIMARY IMPLANTATION, BUT VERIFICATION WOULD REQUIRE ANOTHER X-RAY OF 2020*. FUTHERMORE THE X-RAY ALSO SHOWS LUCENT LINES AROUND NECK AND STEM. REMOVAL OF THE STEM TOGETHER WITH THE NECK NOT SURPRISINGLY SHOULD ALSO BE MANAGEABLE WITHOUT MAJOR DIFFICULTIES. I THEREFORE DO NOT UNDERSTAND, WHY ADDITIONAL PLATING WAS NECESSARY. IT IS UNCLEAR HOW THE ISSUE OF INFECTION HAS BEEN ADDRESSED. WHEN INFECTED COMPLETE REMOVAL OF IMPLANTS IS MANDATORY. THE 2019 X-RAY SHOWS A PERFECTLY IMPLANTED UNCEMENTED THR, NO SIGN OF LOOSENING. SINCE THERE IS NO FAILURE TECHNICALLY IN 2019 ONLY REASON FOR REVISION CAN BE INFECTION ALREADY AT THE RESPECTIVE REVISION". COMPLAINT SOURCE REPORTED THAT WALL BEHIND THE ACETABULUM WAS CRACKED DUE TO A NOT SPECIFIED IMPACT. INFECTION WAS MANAGED BY ADMINISTERING ANTIBIOTIC CONTINUOUSLY. THE REVISION FOR INFECTION WAS PERFORMED IN A SINGLE-STAGE PROCEDURE. UNFORTUNATELY, PRE-OP X-RAYS FROM 2020 WERE NOT AVAILABLE. BASED ON THE INFO PROVIDED AND ANALYZED, WE CANNOT INVESTIGATE FURTHER ABOUT THIS CASE. ACCORDING TO THE DHR REVIEW AND MEDICAL CONSULTANT ASSESSMENT, THIS CASE IS NOT PRODUCT RELATED. PMS DATA: (B)(4). NO CORRECTIVE ACTION 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

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO INFECTION. ACCORDING TO THE COMPLAINT SOURCE, THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. IT WAS REPORTED THAT THE ACETABULUM HAD A FRACTURE. ACCORDING TO THE COMPLAINT SOURCE, ABSORPTION OCCURRED DUE TO INFECTION AND THE CEMENTED CUP (FROM A DIFFERENT MANUFACTURER) MIGRATED TOWARDS THE CENTER. IT WAS REPORTED THAT IN THE ORIGINAL PLAN, ONLY FEMORAL NECK, FEMORAL HEAD AND ACETABULAR CUP WERE GOING TO BE REMOVED. HOWEVER, THE STEM WAS REMOVED TOGETHER WITH THE NECK DUE TO AN INTRA-OPERATIVE ISSUE OCCURRED DURING SURGERY (INTRA-OPERATIVE EVENT WAS REGISTERED AS (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2021-00064). DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE EXPLANTED: FEMORAL MODULAR HEAD - M Ø32MM (PRODUCT CODE 5010.42.322, LOT #1980986 - STER. 1900368). MODULUS MODULAR STEM Ø22 MM (PRODUCT CODE 4310.15.100, LOT #1901684 - STER. 1900123). MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7590.15.040, LOT #1915537 - STER. 1900410). THE ACETABULAR CUP WAS EXPLANTED AS WELL. A MODULUS R MODULAR STEM (PRODUCT CODE 4330.15.220), A MODULUS STANDARD NECK L TAPER B (PRODUCT CODE 7595.15.040), A CERAMIC HEAD D.32MM (PRODUCT CODE 5010.42.322), A PROTRUDED ACETABULAR CUP D.46MM (PRODUCT CODE 5622.50.015), AND A LONG ACETABULAR PLATE D.50MM (PRODUCT CODE 7660.28.110), AND A RECONSTRUCTION PLATE (FROM A DIFFERENT MANUFACTURER) WERE IMPLANTED. SURGEON SATISFIED WITH THE FINAL IMPLANT. PREVIOUS SURGERY ON TOOK PLACE ON (B)(6) 2020. PATIENT IS A FEMALE, 79 YEARS OLD. EVENT HAPPENED IN JAPAN.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO INFECTION. IT WAS REPORTED THAT THE ACETABULUM HAD A FRACTURE. ACCORDING TO THE COMPLAINT SOURCE, ABSORPTION OCCURRED DUE TO INFECTION AND THE CEMENTED CUP (FROM A DIFFERENT MANUFACTURER) MIGRATED TOWARDS THE CENTER. IT WAS REPORTED THAT IN THE ORIGINAL PLAN, ONLY NECK, HEAD AND CUP WERE GOING TO BE REMOVED. HOWEVER, THE STEM WAS REMOVED TOGETHER WITH THE NECK DUE TO AN INTRA-OPERATIVE ISSUE OCCURRED DURING SURGERY. THAT EVENT WAS REGISTERED AS COMPLAINT # (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2021-00064. DURING THE REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED: MODULUS MODULAR STEM Ø22 MM (PRODUCT CODE 4310.15.100, LOT #1901684 - STER. 1900123). FEMORAL MODULAR HEAD - M Ø32MM (PRODUCT CODE 5010.42.322, LOT #1980986 - STER. 1900368). MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7590.15.040, LOT #1915537 - STER. 1900410) THE CUP WAS EXPLANTED AS WELL (DIFFERENT MANUFACTURER). A MODULUS R MODULAR STEM (PRODUCT CODE 4330.15.220), A MODULUS STANDARD NECK L TAPER B (PRODUCT CODE 7595.15.040), A CERAMIC HEAD D.32MM (PRODUCT CODE 5010.42.322), A PROTRUDED ACETABULAR CUP D.46MM (PRODUCT CODE 5622.50.015), AND A LONG ACETABULAR PLATE D.50MM (PRODUCT CODE 7660.28.110), AND A RECONSTRUCTION PLATE (FROM A DIFFERENT MANUFACTURER) WERE IMPLANTED. THE SURGEON WAS REPORTED TO BE SATISFIED WITH THE FINAL IMPLANT. ACCORDING TO THE COMPLAINT SOURCE, THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY ON TOOK PLACE ON (B)(6) 2020. PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272409 FEMORAL MODULAR HEAD - M Ø32MM BIOLOX DELTA HEAD 32MM #M LZO LIMACORPORATE S.P.A. 5010.42.322 1980986

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other