BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, II/32

    MDR report key: 10959543 · Received December 7, 2020

    Report

    Report Number
    0009613350-2020-00568
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    November 23, 2020
    Report Date
    July 22, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL: H2, H6 CORRECTION: B4, G3, G6, H10. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A METASUL LINER, METASUL HEAD AND AN ALLOCLASSIC STEM ON (B)(6), 2005 AND UNDERWENT REVISION ON (B)(6) 2020 DUE TO LYSIS. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: ONE UNDATED AP RADIOGRAPH AND ONE LATERAL IMAGE HAVE BEEN RECEIVED. THE IMAGES DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY. THERE IS A PRONOUNCED AREA OF LYSIS IN THE LOWER THIRD OF THE FEMORAL STEM AND A PROMINENT SEAM LATERALLY ALONG THE STEM. PATIENT DATA: (B)(6), MALE, BORN (B)(6) 1930, 171 CM, 87 KG. NO ADDITIONAL MEDICAL RECORDS WERE PROVIDED; THEREFORE, THE DETAILED SEQUENCE OF EVENTS REMAINS UNKNOWN. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED DUE TO HOSPITAL POLICY; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A METASUL LINER, METASUL HEAD AND AN ALLOCLASSIC STEM ON (B)(6) 2005 AND UNDERWENT REVISION ON (B)(6) 2020 DUE TO LYSIS. BASED ON THE RADIOGRAPH PROVIDED, THE REPORTED LYSIS CAN BE CONFIRMED. NEVERTHELESS, THERE ARE NO IMAGES SHOWING THE ANATOMY OF THE PATIENT BEFORE IMPLANTATION; THEREFORE, POTENTIAL OSSEOUS CHANGES DURING THE TIME IN VIVO CANNOT BE ASSESSED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE AVAILABLE DATA, THE EXACT COURSE AND CAUSE OF THE LYSIS IS UNKNOWN. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    REVISION;LINER, METASUL HEAD AND ALLOCLASSIC STEM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WHICH WAS RECEIVED ON DEC 04, 2020. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED PER AND X-RAYS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO LYSIS.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428692 METASUL, ALPHA INSERT, II/32 METASUL, ALPHA INSERT, II/32 KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2259717

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R