BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM LONGEVITY CONSTRAINED LINER, KK 32 X 56

    MDR report key: 7997375 · Received October 23, 2018

    Report

    Report Number
    0001822565-2018-05835
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    October 11, 2016
    Report Date
    January 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K101730
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT CANNOT BE CONFIRMED AS THE MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS FOR REPORTED COMPONENTS IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT COULD CONTRIBUTE TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00877703202, BIOLOX DELTA OPTION FEM HEAD 32 MM, +0 MM 2842953. UNKNOWN, ZIMMER M/L TAPER® PRESS- FIT EXTENDED NECK OFFSET FEMORAL STEM, SIZE 9, 00875705602, SHELL WITH MULTI HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS, 62466930. 00625006525, BONE SCREW SELF- TAPPING 6.5 MM DIA. 25 MM LENGTH, 63176656. 00625006535, BONE SCREW SELF- TAPPING 6.5 MM DIA. 35 MM LENGTH, 62959152. 00625006540, BONE SCREW SELF- TAPPING 6.5 MM DIA. 40 MM LENGTH, 63171804. 00620105400, REPLACEMENT LOCKING RING FOR USE WITH 54 MM SHELL, 63220996. THE COMPLAINT IS IN INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION ARTHROPLASTY DUE TO INFECTION WITH TREATMENT INCLUDING: HEAD AND POLYETHYLENE LINER SWAP, INCISION AND DRAINAGE, PLACEMENT OF ANTIBIOTIC BEADS, AND PLACEMENT OF WOUND VAC. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836972 CONTINUUM LONGEVITY CONSTRAINED LINER, KK 32 X 56 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 62337992

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R