BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP CEMENT FMRL HD RESUR46MM

    MDR report key: 7078368 · Received December 4, 2017

    Report

    Report Number
    3002806535-2017-01161
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 6, 2017
    Report Date
    May 18, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: M2A-MAGNUM RECAP CUP 52ODX46ID; CATALOG # 157852; LOT #: 1123602. (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: REFERENCE 3002806535-2017-01162.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS WERE RETURNED TO BIOMET UK LTD FOR INVESTIGATION AND FORWARDED TO THE RESEARCH ENGINEER FOR EVALUATION, WHO HAS REPORTED AS FOLLOWS: THE MANUFACTURING HISTORY RECORDS WERE CHECKED AND CONFIRMED THAT THE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE PRE-DEFINED SPECIFICATIONS. A RECAP RESURFACING SYSTEM, COMPOSED OF A Ø46 MM CEMENTED RECAP FEMORAL HEAD AND A 52 X 46 MM POROUS COATED RECAP/MAGNUM ACETABULAR SHELL, WAS SENT TO THE RESEARCH DEPARTMENT FOR EVALUATION. THE COMPONENTS WERE REVISED ON (B)(6) 2017 DUE TO HIGH METAL ION LEVELS DETECTED IN THE PATIENT. NO DATE FOR THE PRIMARY SURGERY WAS PROVIDED; THE MHRS FOR THE RETURNED COMPONENTS SHOWED THAT BOTH PARTS WERE RELEASED TO FINISHED GOODS IN 2006, THEREFORE THE MAXIMUM POSSIBLE IMPLANTATION TIME IS ABOUT 11 YEARS. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT SURGICAL INFORMATION. BOTH THE FEMORAL HEAD AND ACETABULAR SHELL HAVE SCRATCHES ON THEIR ARTICULATING SURFACES THAT MAY BE INDICATIVE OF THIRD-BODY WEAR. POSSIBLE SOURCES OF THIRD-BODY PARTICLES IN THE JOINT SPACE INCLUDE SMALL PIECES OF BONE, CEMENT FROM THE FEMORAL COMPONENT OR DEBRIS FROM THE POROUS COATING OF THE SHELL. HOWEVER, THE PRESENCE OF SUCH PARTICLES CANNOT BE CONFIRMED IN ABSENCE OF X-RAY IMAGES. THE PRESENCE OF WEAR STRIPES AND A WEAR PATCH MAY INDICATE SUBLUXATION OR SUB-OPTIMAL ARTICULATION. THE RECAP TOTAL RESURFACING SYSTEM SURGICAL TECHNIQUE RECOMMENDS THAT THE NECK OF THE FEMORAL COMPONENT IS POSITIONED IN THE CENTRE OF THE FEMORAL NECK, THAT ALL EXCESS CEMENT IS REMOVED AND THAT THE ACETABULAR COMPONENT IS IMPLANTED AT 45 DEGREES INCLINATION AND 20 DEGREES ANTEVERSION. HOWEVER, IT WAS NOT POSSIBLE TO ANALYSE THE POSITIONING OF THE COMPONENTS IN THE ABSENCE OF RADIOGRAPHIC INFORMATION. THE SAME FEMORAL HEAD SIZE WAS CHOSEN FOR THE PRIMARY AND THE REVISION SURGERY, THEREFORE IT CAN BE ASSUMED THAT COMPONENTS WERE SIZED CORRECTLY DURING THE PRIMARY PROCEDURE. INSUFFICIENT DATA ARE MADE AVAILABLE BY THE HOSPITAL TO RENDER A CONCLUSIVE OPINION ON THE CAUSE OF THE REPORTED EVENT. IN ORDER TO INVESTIGATE THE MATTER THOROUGHLY ACCESS IS NEEDED TO CERTAIN PATIENT CO-MORBIDITIES, MRIS, CT SCANS, FULL X-RAYS INCLUDING LATERALS (PRE- AND POST-PRIMARY SURGERY), ROUTINE BLOOD TESTS TO INCLUDE INFLAMMATORY MARKERS, HIP ASPIRATION TO EXCLUDE INFECTION, INTRA OPERATIVE FINDINGS, HISTOLOGICAL FINDINGS AND CONFIRMATION OF ARMD/ALVAL. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED, AND SUBSEQUENTLY A SUPPLEMENTAL REPORT WILL BE PROVIDED WHERE DEEMED REQUIRED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859303 RECAP CEMENT FMRL HD RESUR46MM HIP PROSTHESIS KWA BIOMET UK LTD. N/A 1127998

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R