BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SHELL

    MDR report key: 8913635 · Received August 20, 2019

    Report

    Report Number
    0001825034-2019-03582
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    February 13, 2019
    Report Date
    October 16, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI# (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. HOWEVER, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT FOR THE CUP. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #51-107110 TAPERLOC COMPLETE MICRO FEMORAL STEM LOT #6278522, ITEM #010000847 G7 ACETABULAR LINER LOT #6234106, ITEM #650-1056 BIOLOX DELTA CERAMIC HEAD LOT #2898743, ITEM #650-1066 CERAMIC OPT TYPE 1 TAPER SLEEVE LOT #2920992. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 -03583.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY EIGHT MONTHS POST OP, THE PATIENT UNDERWENT A REVISION DUE TO PAIN, DIFFICULTY WALKING, AND FAILURE OF OSSEOINTEGRATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706401 G7 ACETABULAR SHELL PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 6289138

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R