BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 15X150MM

    MDR report key: 8464704 · Received March 29, 2019

    Report

    Report Number
    0001825034-2019-01501
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    November 6, 2017
    Report Date
    September 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  CONCOMITANT MEDICAL PRODUCTS : CATALOG NUMBER:010000820 LOT NUMBER:6029250 BRAND NAME: G7 LINER, CATALOG NUMBER:650-0661 LOT NUMBER: 2017011347 BRAND NAME: DELTA CERAMIC HEAD, CATALOG NUMBER:010000666 LOT NUMBER:6062652 BRAND NAME: G7 SHELL. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE .SUBSEQUENTLY PATIENT FELL SIX (6) WEEKS POST OPERATION REQUIRING HOSPITALIZATION, THE PATIENT THEN WENT ONTO DEVELOPING THIGH PAIN. FINALLY, THE PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY (17) MONTHS POST PRIMARY IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 010000820, LOT NUMBER: 6029250, BRAND NAME: G7 LINER; CATALOG NUMBER: 51-104150, LOT NUMBER: 6032528, BRAND NAME:TAPERLOC STEM; CATALOG NUMBER: 650-0661, LOT NUMBER: UNKNOWN, BRAND NAME: DELTA CERAMIC HEAD; CATALOG NUMBER: 010000666, LOT NUMBER: 6062652, BRAND NAME: G7 SHELL. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01497, 0001825034-2019-01500, 0001825034-2019-01502. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT THE PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY 18 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259131 TPRLC 133 T1 PPS HO 15X150MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6032528

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R