BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 PPS HO 10.0

    MDR report key: 7531263 · Received May 21, 2018

    Report

    Report Number
    0001825034-2018-03092
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    April 23, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X RAYS. X-RAY REVIEW: RIGHT TOTAL HIP ARTHROPLASTY WITH EVIDENCE OF SUBSIDENCE AND ASSOCIATED JOINT SPACE NARROWING, LIKELY LIMITING RANGE OF MOTION WAS NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED TWO MONTHS POST IMPLANTATION DUE TO LOOSENING. THE STEM SANK WITHIN THE FEMUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE -(B)(6) 2018. CONCOMITANT MEDICAL PRODUCTS: 163669, 32MM MOD HEAD COCR STD NECK, J6070741, 010000665, G7 PPS LTD ACET SHELL 56F, 6209960, 010000928, G7 HI-WALL E1 LINER 32MM F, 6180830. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03093.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED TWO MONTHS POST-IMPLANTATION DUE TO DISLOCATION. THE STEM SANK WITHIN THE FEMUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371201 TPRLC 133 FP TYPE1 PPS HO 10.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6104976

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R