BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TTAP SHELL

    MDR report key: 7822580 · Received August 28, 2018

    Report

    Report Number
    0001825034-2018-08538
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    July 31, 2017
    Report Date
    November 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. X-RAYS REVEALED AN OVERALL FIT AND ALIGNMENT OF THE IMPLANTS. MILD LUCENCY ALONG THE SUPERIOR AND INFERIOR ASPECT OF THE CUP. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 165170 ¿ TTAP/ST LINER HIGH WALL ¿ 760740, 162312 ¿ BI-METRIC POROUS FEMORAL ¿ 200740, 163145 ¿ MODULAR HEAD - 608570. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION ON UNKNOWN SIDE AT AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION DUE TO LOOSENING OF THE ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664601 TTAP SHELL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 191210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R