BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER METASUL LARGE DIAMETER HEAD (LDH)

    MDR report key: 7103848 · Received December 11, 2017

    Report

    Report Number
    0009613350-2017-01724
    Event Type
    Injury
    Date Received
    December 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ZIMMER GMBH
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM/LOT NUMBERS ARE AVAILABLE. DEVICE HISTORY RECORDS: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. EVENT DESCRIPTION: EVENT SUMMARY: FROM THE STUDY, 16 PATIENTS WERE IMPLANTED WITH ZIMMER METASUL LDH AND UNDERWENT REVISION SURGERY DUE TO ADVERSE REACTIONS TO METAL DEBRIS. DURING INVESTIGATION, THERE WERE NOTED WITH HIGH WEAR AND CORROSION AT HEAD AND NECK JUNCTION. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. CONCLUSION SUMMARY: IT IS ONLY KNOWN THAT 16 PATIENTS HAD ZIMMER METASUL LDH AND UNDERWENT REVISION SURGERY DUE TO ADVERSE REACTIONS TO METAL DEBRIS. IT IS ALSO REPORTED THAT RETRIEVAL INVESTIGATION SHOWED WEAR AND CORROSION AT HEAD AND NECK JUNCTION, BUT NEITHER THE DETAILED RESULTS NOR PICTURES REGARDING ZIMMER COMPONENTS ARE REPORTED. DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ENTITLED "A COMPARISON STUDY OF STEM TAPER MATERIAL LOSS AT SIMILAR AND MIXED METAL HEAD-NECK TAPER JUNCTIONS" WAS RECEIVED, WHERE THE AUTHORS EVALUATED THE WEAR OF DIFFERENT STEM TAPERS IN HIP ARTHROPLASTY SYSTEMS. THE PURPOSE OF THIS JOURNAL ARTICLE WAS TO ANALYSE THE VOLUMETRIC MATERIAL LOSS AT THE TAPER SURFACES OF EXPLANTED HIP ARTHOPLASTIES USED WITH EITHER A TI ALLOY OR COCR FEMORAL STEM. EXPLANTS WERE COLLECTED BETWEEN 2008 AND 2014. FOR THE PRESENT CASE, IT WAS REPORTED IN THE RECEIVED JOURNAL ARTICLE THAT 16 PATIENTS WHO WERE IMPLANTED WITH ZIMMER METASUL LDH, WERE NOTED WITH CORROSION AND WEAR. SOURCE: "THE BONE & JOINT JOURNAL" 2017;99-B:1304¿12. D. J. LANGTON, R. P. SIDAGINAMALE, T. J. JOYCE, R. D. MEEK, J. G. BOWSHER, D. DEEHAN, A. V. F. NARGOL AND J. P. HOLLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885717 UNKNOWN ZIMMER METASUL LARGE DIAMETER HEAD (LDH) KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R