BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 52E

    MDR report key: 8356445 · Received February 20, 2019

    Report

    Report Number
    0001825034-2019-00416
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    November 6, 2018
    Report Date
    January 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 11-107017, ITEM NAME: FREEDOM CONSTR HD 36MM T1 -3MM, LOT NUMBER: 295100; ITEM NUMBER: 010000983, ITEM NAME: G7 FREEDOM CONST E1 LNR 36MM E, LOT NUMBER: 3217325; ITEM NUMBER: NI, ITEM NAME: UNKNOWN FEMORAL STEM, LOT NUMBER: NI; ITEM# 010000998 G7 SCREW 6.5MM X 25MM LOT# 3085124; ITEM#103203  TAPERLOC POR FMRL 9X137 LOT# 005300.  REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. X-RAYS WERE PROVIDED AND THE REVIEW IDENTIFIED SCREW WAS FRACTURED LATERALLY. LUCENCY SURROUNDING THE SUPERIOR AND SUPEROLATERAL ASPECT OF THE ACETABULAR CUP SUGGESTING LOOSENING. THE CUP WAS HORIZONTALLY ORIENTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -09004 - 3.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY REVISION DUE TO A FRACTURED SCREW, PAIN, AND AN ACETABULAR DEFECT. A CUSTOM TRIFLANGE WAS IMPLANTED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148224 G7 PPS LTD ACET SHELL 52E PROSTHESIS HIP PBI ZIMMER BIOMET, INC. N/A 3087066

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R