BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 60 MM O.D. SIZE MM FOR USE WITH MM LINERS

    MDR report key: 8807450 · Received July 19, 2019

    Report

    Report Number
    0001822565-2019-03108
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    September 1, 2018
    Report Date
    July 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 00875706001, LOT NUMBER: 61920214, BRAND NAME: ACETABULAR SHELL. CATALOG NUMBER: 00771100600, LOT NUMBER: 61772616, BRAND NAME: M/L TAPER STEM. CATALOG NUMBER: 00877004002, LOT NUMBER: 2635169, BRAND NAME: METASUL HEAD UNKNOWN METASUL LINER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-03107. 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. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, GMI & GME RUPTURE APPROXIMATELY 7 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601113 SHELL WITH CLUSTER HOLES POROUS 60 MM O.D. SIZE MM FOR USE WITH MM LINERS PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61920214

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other