BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    UNKNOWN BEARING

    MDR report key: 19976901 · Received August 13, 2024

    Report

    Report Number
    0009613350-2024-00364
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    January 31, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE: UNITED KINGDOM. LITERATURE: LACHLAN W. ARTHUR / PRIYANKA GHOSH / HASAN R. MOHAMMAD /STEFANO CAMPI / BENJAMIN J. L. KENDRICK / DAVID W. MURRAY / STEPHEN J. MELLON. POLYETHYLENE BEARING WEAR IS COMPARABLE FOR CEMENTED AND CEMENTLESS OXFORD UNICOMPARTMENTAL KNEE REPLACEMENTS: TEN-YEAR RESULTS OF A RANDOMIZED CONTROLLED TRIAL. WILEY (PAGES 1-13). DOI: 10.1002/KSA.12042 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINATE THIS MDR WAS NOT FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL CONTINUE TO BE REPORTED UNDER MFR NUMBER (B)(4) (UK).

    Description of Event or Problem · 0

    IT WAS REPORTED IN JOURNAL ARTICLE THAT A GROUP OF PATIENTS UNDERWENT A KNEE REPLACEMENT. THE PURPOSE OF THE STUDY WAS TO MEASURE BEARING WEAR AT 10 YEARS IN PATIENTS FROM A RANDOMIZED TRIAL. THE STUDY ASSESSED WEAR RATES IN CEMENTED AND CEMENTLESS GROUPS WITH A CLINICALLY SIGNIFICANT WEAR RATE ESTABLISHED. THE ARTICLE NOTES THAT THE WEAR RATE OBSERVED IN THE CEMENTLESS GROUP (23 PATIENTS) WAS HIGHER THAN THE CLINICALLY SIGNIFICANT THRESHOLD. THIS IS AN INCIDENTAL FINDING WITH RSA ANALYSIS, AND THE PATIENTS REMAINED ASYMPTOMATIC WITH NO TREATMENT OR INTERVENTION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINATE THIS MDR WAS NOT FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL CONTINUE TO BE REPORTED UNDER MFR NUMBER (B)(4) (UK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894831 UNKNOWN BEARING PROSTHESIS, KNEE LZO ZIMMER GMBH N/A UNKNOWN
    518592 UNKNOWN BEARING PROSTHESIS, KNEE LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown