BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 BM HO 10.0

    MDR report key: 8437936 · Received March 20, 2019

    Report

    Report Number
    0001825034-2019-01250
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 20, 2019
    Report Date
    July 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 110024465 G7 DUAL MOBILITY LINER 46MM G LOT# 274050, ITEM# EP-200152 ACT ARTIC E1 HIP BRG 28X46MM LOT# 135070, ITEM# 650-1157 DELTA CER FEM HD 28/+3MM T1 LOT# 2018100075. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER: K101086.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY AND SUBSEQUENTLY SIX DAYS LATER THE PATIENT WAS REVISED FOR A LOOSE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229863 TPRLC 133 MP TYPE1 BM HO 10.0 HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 3482701

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R