BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX DELTA TAPER LINER

    MDR report key: 15637303 · Received October 20, 2022

    Report

    Report Number
    0009613350-2022-00552
    Event Type
    Injury
    Date Received
    October 20, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN BIOLOX DELTA FEMORAL HEAD 48MM, UNKNOWN MAXERA 58MM ACETABULUM. REPORT SOURCE: FOREIGN ¿ CANADA. JOURNAL: LINER DISSOCIATION IN A LARGE-DIAMETER CERAMIC-BEARING ACETABULAR COMPONENT: A REPORT OF FIVE CASESLAZAROS KOSTRETZIS, SAGI MARTINOV, MARTIN LAVIGNE, VINCENT MASSÉ, PASCAL?ANDRÉ VENDITTOLI: BMC MUSCULOSKELETAL DISORDERS (2022); HTTPS://DOI.ORG/10.1186/S12891-022-05082-6. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED TWO AREAS OF METAL TRANSFER MARKS. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURES. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BILATERAL TOTAL HIP ARTHROPLASTIES WITH EVIDENCE OF RIGHT HIP CERAMIC LINER DISPLACEMENT AS WELL AS PNEUMARTHROSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHTY-SEVEN-MONTHS POST IMPLANTATION DUE TO A SHARP PAIN. RADIOGRAPHIC EVIDENCE DISPLAYED CERAMIC INSERT SEPARATION AND PNEUMARTHROSIS. DURING THE REVISION, THE CAPSULE WAS FOUND WIDE-OPEN POSTERIORLY, WITH A LARGE COLLECTION OF YELLOWISH FLUID, THE TITANIUM SHELL WEAR WITH SIGNS OF CORROSION AND TITANIUM DEBRIS WERE OBSERVED. THE CERAMIC LINER WAS DISPLACED AND FOUND MOBILE. THE MAXERA CUP WAS REMOVED AND REPLACED WITH A 4MM LARGER CUP. THE PATIENT WAS OBSERVED FOR 8 MONTHS, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002617 UNKNOWN BIOLOX DELTA TAPER LINER HIP PROSTHESIS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H SEE H10 NARRATIVE