BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SHELL

    MDR report key: 8915957 · Received August 21, 2019

    Report

    Report Number
    0001825034-2019-03589
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    December 17, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #51-107110, TAPERLOC COMPLETE MICRO FEMORAL STEM, LOT #6283007; ITEM #010000847, G7 ACETABULAR LINER, LOT #628387; ITEM #650-1056, BIOLOX DELTA CERAMIC HEAD, LOT #2898741; ITEM #650-1066, TAPER ADAPTER, LOT #2922739. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2019-03590.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BILATERAL PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWO AND A HALF MONTHS POST OP THE PATIENT BEGAN EXPERIENCING PAIN. THE PATIENT IS SCHEDULED TO HAVE A REVISION SURGERY DUE TO PAIN AND IMPLANT LOOSENING. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708552 G7 ACETABULAR SHELL PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 6289131

    Patients

    Seq Age Sex Outcome Treatment
    1